Back to resultsEffect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)
Primary Purpose
Hyperkalemia
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sodium Zirconium Cyclosilicate (SZC)
SZC Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperkalemia focused on measuring Hemodialysis, Hyperkalemia, Cardiovascular Events, Atrial Fibrillation, Ventricular Tachycardia
Eligibility Criteria
Inclusion Criteria:
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
- Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses
- Must be ≥ 18 years of age, at the time of signing the ICF. For participants < 20 years of age and enrolled in Japan, a written informed consent should be obtained from the participant and his or her legally acceptable representative
- Receiving hemodialysis (or hemodiafiltration) 3 times a week for treatment of ESRD for ≥ 4 months before enrollment
- Must have hemodialysis access consisting of an arteriovenous fistula, arteriovenous graft, or tunneled (permanent) catheter which is expected to remain in place for the entire duration of the study
- At least 2 out of 3 pre-dialysis S K ≥ 5.5 mmol/L after the LIDI during screening
- Negative pregnancy test for female participants of childbearing potential
- Female participants must be 1 year postmenopausal, surgically sterile, or using one highly effective form of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly). They should have been stable on their chosen method of birth control for a minimum of 3 months before entering the study and willing to remain on the birth control until 12 weeks after the last dose
Exclusion Criteria:
- Pseudohyperkalemia secondary to hemolyzed blood specimen (this situation is not considered screening failure, sampling or full screening can be postponed to a later time as applicable)
- Presence of cardiac arrhythmias or conduction defects that require immediate treatment
- Participants who have a pacemaker or implantable cardiac defibrillator
- Any medical condition, including active, clinically significant infection or liver disease, that in the opinion of the investigator or sponsor may pose a safety risk to a participant in this study, confound safety or efficacy assessment and jeopardize the quality of the data, or interfere with study participation, or any other restrictions or contraindications in the local prescribing information for SZC
- History of QT prolongation associated with other medications that required discontinuation of that medication
- Congenital long QT syndrome
- QTcF > 550 msec
- Atrial Fibrillation requiring immediate/urgent intervention at screening or randomizations
- Treated with sodium polystyrene sulfonate (SPS, Kayexalate, Resonium), calcium polystyrene sulfonate (CPS Resonium Calcium), patiromer (Veltassa), or SZC (Lokelma) within 7 days before screening or anticipated requiring chronic use of any of these agents during the study. If patient requires rescue therapy (potassium binder or dialysate S-K change during screening period), the patient will be screen failed
- Participation in another clinical study with an investigational product administered within one month before screening
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements
- Previous randomization in the present study
- Females who are pregnant (confirmed with positive pregnancy test or a uterine ultrasound if pregnancy test result is questionable), breastfeeding, or planning to become pregnant during the study
- Known hypersensitivity or previous anaphylaxis to SZC or to components thereof
- Scheduled date for living donor kidney transplant
- Sustained Ventricular Tachycardia > 30 seconds requiring assessment / intervention
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sodium Zirconium Cyclosilicate
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Time to first occurrence of SCD, stroke, or hospitalization/intervention/ED visit due to arrhythmias (atrial fibrillation [AF], bradycardia, asystole, ventricular tachyarrhythmia [VF, VT, etc.])
Secondary Outcome Measures
S-K of 4.0-5.5 mmol/L (yes/no) after the long interdialytic interval (LIDI) at the 12 month visit
Time to first occurrence of hospitalization/intervention/ED visit due to arrhythmias (AF, bradycardia, asystole, Ventricular tachyarrhythmia [VF, VT etc.])
Number of hospitalizations/interventions/ED visits due to arrhythmias (AF, bradycardia, asystole, Ventricular tachyarrhythmia [VF, VT etc.])
Time to first instance of rescue therapy use for hyperkalemia
S-K > 6.5 mmol/L (yes/no) after the LIDI at the 12 month visit
Time to SCD
Time to first occurrence of stroke
Time to cardiovascular (CV) death
Time to death of any cause
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04847232
Brief Title
Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)
Official Title
An International, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
March 13, 2026 (Anticipated)
Study Completion Date
March 13, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC) on arrhythmia-related cardiovascular outcomes in participants on chronic hemodialysis with recurrent hyperkalemia.
Detailed Description
This is an international, multicenter, event-driven, randomized, double-blind, parallel group, placebo-controlled study, evaluating the utility of SZC versus placebo to reduce the incidence of sudden cardiac death (SCD), stroke, and arrhythmia-related hospitalizations, interventions, and emergency department (ED) visits in participants on chronic hemodialysis with recurrent hyperkalemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperkalemia
Keywords
Hemodialysis, Hyperkalemia, Cardiovascular Events, Atrial Fibrillation, Ventricular Tachycardia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sodium Zirconium Cyclosilicate
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Sodium Zirconium Cyclosilicate (SZC)
Other Intervention Name(s)
Lokelma TM
Intervention Description
Powder for oral suspension in a sachet. A dose is titrated in 5 g increments during a period of 4 weeks from 5 g up to 15 g qd on non-dialysis days. Afterward, the dose is adjusted monthly (or more frequent based on clinical judgment) depending on the current potassium value as measured after the long interdialytic interval (LIDI).
Intervention Type
Drug
Intervention Name(s)
SZC Placebo
Intervention Description
Powder for oral suspension in a sachet. A dose is titrated in 5 g increments during a period of 4 weeks from 5 g up to 15 g qd on non-dialysis days. Afterward, the dose is adjusted monthly (or more frequent based on clinical judgment) depending on the current potassium value as measured after the LIDI.
Primary Outcome Measure Information:
Title
Time to first occurrence of SCD, stroke, or hospitalization/intervention/ED visit due to arrhythmias (atrial fibrillation [AF], bradycardia, asystole, ventricular tachyarrhythmia [VF, VT, etc.])
Time Frame
From randomization visit through study completion during study visits every 3 months, over an average of 3 years
Secondary Outcome Measure Information:
Title
S-K of 4.0-5.5 mmol/L (yes/no) after the long interdialytic interval (LIDI) at the 12 month visit
Time Frame
Evaluated at 12 months after randomization
Title
Time to first occurrence of hospitalization/intervention/ED visit due to arrhythmias (AF, bradycardia, asystole, Ventricular tachyarrhythmia [VF, VT etc.])
Time Frame
From randomization visit through study completion during study visits every 3 months, over an average of 3 years
Title
Number of hospitalizations/interventions/ED visits due to arrhythmias (AF, bradycardia, asystole, Ventricular tachyarrhythmia [VF, VT etc.])
Time Frame
From randomization visit through study completion during study visits every 3 months, over an average of 3 years
Title
Time to first instance of rescue therapy use for hyperkalemia
Time Frame
From randomization visit through study completion during study visits every 3 months, over an average of 3 years
Title
S-K > 6.5 mmol/L (yes/no) after the LIDI at the 12 month visit
Time Frame
Evaluated at 12 months after randomization
Title
Time to SCD
Time Frame
From randomization visit through study completion during study visits every 3 months, over an average of 3 years
Title
Time to first occurrence of stroke
Time Frame
From randomization visit through study completion during study visits every 3 months, over an average of 3 years
Title
Time to cardiovascular (CV) death
Time Frame
From randomization visit through study completion during study visits every 3 months, over an average of 3 years
Title
Time to death of any cause
Time Frame
From randomization visit through study completion during study visits every 3 months, over an average of 3 years
Other Pre-specified Outcome Measures:
Title
Adverse Events (AEs)/ Serious Adverse Events (SAEs)
Time Frame
From randomization/ screening visit through study completion during study visits every 3 months, over an average of 3 years
Title
Events of pre-dialysis hypokalemia (S-K < 3.0 mmol/L)
Time Frame
From randomization visit through study completion during study visits every 3 months, over an average of 3 years
Title
Change in interdialytic weight gain (kg) as compared to baseline
Time Frame
From randomization visit through study completion during study visits every 3 months, over an average of 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses
Must be ≥ 18 years of age, at the time of signing the ICF.
Receiving hemodialysis (or hemodiafiltration) 3 times a week for treatment of ESRD for ≥ 4 months before enrollment
Must have hemodialysis access consisting of an arteriovenous fistula, arteriovenous graft, or tunneled (permanent) catheter which is expected to remain in place for the entire duration of the study
At least 2 out of 3 pre-dialysis S K ≥ 5.5 mmol/L after the LIDI during screening
Negative pregnancy test for female participants of childbearing potential
Female participants must be 1 year postmenopausal, surgically sterile, or using one highly effective form of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly). They should have been stable on their chosen method of birth control for a minimum of 3 months before entering the study and willing to remain on the birth control until 12 weeks after the last dose
Exclusion Criteria:
Pseudohyperkalemia secondary to hemolyzed blood specimen (this situation is not considered screening failure, sampling or full screening can be postponed to a later time as applicable)
Presence of cardiac arrhythmias or conduction defects that require immediate treatment
Participants who have a pacemaker or implantable cardiac defibrillator
Any medical condition, including active, clinically significant infection or liver disease, that in the opinion of the investigator or sponsor may pose a safety risk to a participant in this study, confound safety or efficacy assessment and jeopardize the quality of the data, or interfere with study participation, or any other restrictions or contraindications in the local prescribing information for SZC
History of QT prolongation associated with other medications that required discontinuation of that medication
Congenital long QT syndrome
QTcF > 550 msec
Atrial fibrillation requiring immediate/urgent intervention at screening or randomizations
Treated with sodium polystyrene sulfonate (SPS, Kayexalate, Resonium), calcium polystyrene sulfonate (CPS Resonium Calcium), patiromer (Veltassa), or SZC (Lokelma) within 7 days before screening or anticipated requiring chronic use of any of these agents during the study. If participant requires rescue therapy (potassium binder or dialysate S-K change during screening period), the participant will be screen failed
Participation in another clinical study with an investigational product, device, or non-standard hemodialysis procedure administered within one month before screening
Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements
Previous randomization in the present study
Females who are pregnant (confirmed with positive pregnancy test or a uterine ultrasound if pregnancy test result is questionable), breastfeeding, or planning to become pregnant during the study
Known hypersensitivity or previous anaphylaxis to SZC or to components thereof
Scheduled date for living donor kidney transplant
Sustained Ventricular Tachycardia > 30 seconds requiring assessment / intervention
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Fishbane, Professor, MD
Organizational Affiliation
North Shore University Hospital, 300 Community Drive, Manhasset, NY 11030
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lynwood
State/Province
California
ZIP/Postal Code
90262
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Vacaville
State/Province
California
ZIP/Postal Code
95687
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Victorville
State/Province
California
ZIP/Postal Code
92394
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bloomfield
State/Province
Connecticut
ZIP/Postal Code
06002
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Statesboro
State/Province
Georgia
ZIP/Postal Code
30458
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70815
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
New Iberia
State/Province
Louisiana
ZIP/Postal Code
70563
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2689
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Roseville
State/Province
Michigan
ZIP/Postal Code
48066
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Brookhaven
State/Province
Mississippi
ZIP/Postal Code
39601
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Columbus
State/Province
Mississippi
ZIP/Postal Code
39705
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jersey City
State/Province
New Jersey
ZIP/Postal Code
07305
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28208
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29306
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Conroe
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79925
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79935
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Greenville
State/Province
Texas
ZIP/Postal Code
75402
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78251
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Corrientes
ZIP/Postal Code
W3400AMZ
Country
Argentina
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Córdoba
ZIP/Postal Code
X5016LIG
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Junín
ZIP/Postal Code
6000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mar del Plata
ZIP/Postal Code
B7600DBZ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pergamino
ZIP/Postal Code
B2700LDK
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Luis
ZIP/Postal Code
5700
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Luis
ZIP/Postal Code
D5700CTA
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santa Rosa
ZIP/Postal Code
L6300
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sarandi
ZIP/Postal Code
B1872EEC
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Belo Horizonte
ZIP/Postal Code
30150-221
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Brasilia
ZIP/Postal Code
70390-700
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Curitiba
ZIP/Postal Code
80230-130
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Curitiba
ZIP/Postal Code
80440-020
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Joinville
ZIP/Postal Code
89227-680
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Maringá
ZIP/Postal Code
87060-040
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90160-093
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Recife
ZIP/Postal Code
50720-635
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ribeirao Preto
ZIP/Postal Code
14025-170
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rio De Janeiro
ZIP/Postal Code
20551-030
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
05403-9000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
04038-031
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
05024-040
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Dupnitsa
ZIP/Postal Code
2600
Country
Bulgaria
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Gotse Delchev
ZIP/Postal Code
2900
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Haskovo
ZIP/Postal Code
6300
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Razlog
ZIP/Postal Code
2760
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Samokov
ZIP/Postal Code
2000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sandanski
ZIP/Postal Code
2800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Silistra
ZIP/Postal Code
7500
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Smolyan
ZIP/Postal Code
3700
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Yambol
ZIP/Postal Code
8600
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 5N5
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sydney
State/Province
Nova Scotia
ZIP/Postal Code
B1P 1P3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3M 0B2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2T2
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2T 3B3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changchun
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410004
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
430033
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changzhou
ZIP/Postal Code
213000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610500
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Dongguan
ZIP/Postal Code
523009
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Foshan
ZIP/Postal Code
528000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fuzhou
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510800
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
511400
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guilin
ZIP/Postal Code
541000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guiyang
ZIP/Postal Code
550002
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guiyang
ZIP/Postal Code
550004
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Haikou
ZIP/Postal Code
570311
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310014
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hefei
ZIP/Postal Code
230601
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hengyang
ZIP/Postal Code
421001
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hohhot
ZIP/Postal Code
10050
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Huai'an
ZIP/Postal Code
223300
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jinan
ZIP/Postal Code
250031
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jinhua
ZIP/Postal Code
322100
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jiujiang
ZIP/Postal Code
332000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kunming
ZIP/Postal Code
650032
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lanzhou
ZIP/Postal Code
730000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lanzhou
ZIP/Postal Code
730030
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Luoyang
ZIP/Postal Code
471003
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanchang
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanyang
ZIP/Postal Code
473000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ningbo
ZIP/Postal Code
315010
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Panjin
ZIP/Postal Code
124009
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pingxiang
ZIP/Postal Code
337055
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Qingdao
ZIP/Postal Code
266011
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200240
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
201199
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
201200
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
CN-200120
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Shengyang
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shenzhen
ZIP/Postal Code
518020
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Siping
ZIP/Postal Code
136000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taian
ZIP/Postal Code
271099
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taiyuan
ZIP/Postal Code
030012
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300121
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300192
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Urumqi
ZIP/Postal Code
CN-830004
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wenzhou
ZIP/Postal Code
325027
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430010
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
WuHan
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430071
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Wuhu
ZIP/Postal Code
241000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wuxi
ZIP/Postal Code
214023
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Xiamen
ZIP/Postal Code
361004
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Xianyang
ZIP/Postal Code
712000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Xinxiang
ZIP/Postal Code
453000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Yibin
ZIP/Postal Code
644000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Yinchuan
ZIP/Postal Code
750004
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zhuzhou
ZIP/Postal Code
412007
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ceske Budejovice
ZIP/Postal Code
370 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Havlickuv Brod
ZIP/Postal Code
580 22
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jilemnice
ZIP/Postal Code
514 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Klatovy
ZIP/Postal Code
339 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Liberec
ZIP/Postal Code
460 63
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nove Mesto na Morave
ZIP/Postal Code
692 31
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Plzen
ZIP/Postal Code
32300
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tabor
ZIP/Postal Code
390 03
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Trebic
ZIP/Postal Code
674 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cloppenburg
ZIP/Postal Code
49661
Country
Germany
Individual Site Status
Completed
Facility Name
Research Site
City
Düsseldorf
ZIP/Postal Code
40210
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Heilbronn
ZIP/Postal Code
74076
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Minden
ZIP/Postal Code
32429
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Potsdam
ZIP/Postal Code
14467
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Potsdam
ZIP/Postal Code
14473
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Dunaújváros
ZIP/Postal Code
2400
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Hatvan
ZIP/Postal Code
3000
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Karcag
ZIP/Postal Code
5300
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nagykanizsa
ZIP/Postal Code
8800
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Coimbatore
ZIP/Postal Code
641018
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nadiad
ZIP/Postal Code
387001
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110017
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Puducherry
ZIP/Postal Code
605006
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Pune
ZIP/Postal Code
411013
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Vijayawada
ZIP/Postal Code
522002
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bassano del Grappa
ZIP/Postal Code
36061
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Caserta
ZIP/Postal Code
81100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20142
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Monza
ZIP/Postal Code
20052
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Parma
ZIP/Postal Code
43100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pesaro
ZIP/Postal Code
61121
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Verona
ZIP/Postal Code
37124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fujisawa-shi
ZIP/Postal Code
251-0041
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
810-0004
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hamamatsu-shi
ZIP/Postal Code
434-0018
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kawasaki-shi
ZIP/Postal Code
210-0852
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kumagaya-shi
ZIP/Postal Code
360-0831
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kumamoto-shi
ZIP/Postal Code
861-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kurashiki-shi
ZIP/Postal Code
710-0051
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Kyoto-shi
ZIP/Postal Code
600-8216
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Moriya-shi
ZIP/Postal Code
3020118
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nagano-shi
ZIP/Postal Code
380-0904
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nagasaki-shi
ZIP/Postal Code
852-8053
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nakagami-gun
ZIP/Postal Code
901-2393
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nakano-shi
ZIP/Postal Code
383-8505
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Okinawa-shi
ZIP/Postal Code
904-2143
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Omihachiman-shi
ZIP/Postal Code
523-0082
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sashima-gun
ZIP/Postal Code
306-0433
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Setagaya-ku
ZIP/Postal Code
158-0094
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shiroishi-shi
ZIP/Postal Code
989-0231
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tamana-shi
ZIP/Postal Code
865-0016
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toride-shi
ZIP/Postal Code
302-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tsuchiura-shi
ZIP/Postal Code
300-0062
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tsuchiura-shi
ZIP/Postal Code
300-0835
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tsukuba-shi
ZIP/Postal Code
305-0861
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ushiku-shi
ZIP/Postal Code
300-1296
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Yatomi-shi
ZIP/Postal Code
498-0006
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Alor Setar
ZIP/Postal Code
5460
Country
Malaysia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Batu Caves
ZIP/Postal Code
68100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ipoh
ZIP/Postal Code
30990
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Melaka
ZIP/Postal Code
75400
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seri Manjung
ZIP/Postal Code
32040
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Culiacán
ZIP/Postal Code
80230
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
D.F
ZIP/Postal Code
14000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mazatlán
ZIP/Postal Code
82000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mexico City
ZIP/Postal Code
0 3100
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Morelia
ZIP/Postal Code
58260
Country
Mexico
Individual Site Status
Terminated
Facility Name
Research Site
City
San Luis Potosí
ZIP/Postal Code
78250
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Xalapa
ZIP/Postal Code
91020
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zapopan
ZIP/Postal Code
45138
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bellavista
ZIP/Postal Code
CALLAO 2
Country
Peru
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Cusco
ZIP/Postal Code
CUSCO 01
Country
Peru
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
14
Country
Peru
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15036
Country
Peru
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15046
Country
Peru
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15088
Country
Peru
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 01
Country
Peru
Individual Site Status
Recruiting
Facility Name
Research Site
City
Piura
ZIP/Postal Code
20001
Country
Peru
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-462
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kielce
ZIP/Postal Code
25-736
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Leżajsk
ZIP/Postal Code
37-300
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Oleśnica
ZIP/Postal Code
56-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Olkusz
ZIP/Postal Code
32-300
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Opole
ZIP/Postal Code
46-020
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
60-214
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Pszczyna
ZIP/Postal Code
43-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Słupsk
ZIP/Postal Code
76-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tczew
ZIP/Postal Code
83-110
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wołomin
ZIP/Postal Code
05-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
50-981
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
90-153
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
92-213
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Żory
ZIP/Postal Code
44-240
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Żyrardów
ZIP/Postal Code
96-300
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kemerovo
ZIP/Postal Code
650000
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Kolomna
ZIP/Postal Code
140402
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
129344
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Mytischi
ZIP/Postal Code
141009
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Omsk
ZIP/Postal Code
644112
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Penza
ZIP/Postal Code
440034
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Rostov on Don
ZIP/Postal Code
344029
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
191167
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
190103
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Banská Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Bratislava
ZIP/Postal Code
85107
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Komárno
ZIP/Postal Code
945 75
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kosice
ZIP/Postal Code
04011
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lucenec
ZIP/Postal Code
984 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Puchov
ZIP/Postal Code
2001
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Spišská Nová Ves
ZIP/Postal Code
052 01
Country
Slovakia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Žilina
ZIP/Postal Code
010 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Alcala de Henares
ZIP/Postal Code
28805
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Keelung
ZIP/Postal Code
20448
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Linkou
ZIP/Postal Code
244
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
New Taipei
ZIP/Postal Code
220
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
New Taipei
ZIP/Postal Code
23561
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei City
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei City
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Adapazarı
ZIP/Postal Code
54100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kahramanmaras
ZIP/Postal Code
46100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chernivtsі
ZIP/Postal Code
58001
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Ivano-Frankivsk
ZIP/Postal Code
78018
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
01004
Country
Ukraine
Individual Site Status
Completed
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
02125
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Mykolaiv
ZIP/Postal Code
54058
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Odesa
ZIP/Postal Code
65074
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Ternopil
ZIP/Postal Code
46001
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Uzhhorod
ZIP/Postal Code
88018
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Zaporizhzhia
ZIP/Postal Code
69001
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Zaporizhzhia
ZIP/Postal Code
69600
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Bristol
ZIP/Postal Code
BS105NB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
London
ZIP/Postal Code
SE1 2PR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Swansea
ZIP/Postal Code
SN6 6NL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wolverhampton
ZIP/Postal Code
WV10 OQP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bien Hoa
ZIP/Postal Code
810000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Da Nang
ZIP/Postal Code
55000
Country
Vietnam
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
10000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ho Chi Minh City
ZIP/Postal Code
70000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
10000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Hue
ZIP/Postal Code
530000
Country
Vietnam
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Learn more about this trial
Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)
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