search
Back to results

Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge Study (CONTINUITY)

Primary Purpose

Hyperkalaemia, Chronic Kidney Disease

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Sodium Zirconium Cyclosilicate (SZC)
Local standard of care
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperkalaemia focused on measuring sodium zirconium cyclosilicate, Hyperkalaemia after discharge at the hospital

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must be 18 years of age or older, at the time of signing the informed consent
  • Admitted to hospital (inpatient care; directly or from ED)

  • With:

    1. diagnosed stage 3b to 5 CKD And/or
    2. eGFR < 45 ml/min/1.73 m2 at, or within 3 months of, study screening, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Levey et al, 2009).

Note: Race/ethnicity should not be included in CKD-EPI equation calculation.

  • Hyperkalaemia at current ED visit/hospital admission as defined by site's local practice and K+ must be between > 5.0 and ≤ 6.5 mmol/L.
  • Male or female
  • Capable and willing of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

  • Myocardial infarction, stroke, seizure, or a thrombotic/thromboembolic event (eg, deep vein thrombosis or pulmonary embolism, but excluding vascular access thrombosis) within 12 weeks prior to screening
  • Unable to take oral SZC drug mix
  • With a life expectancy of less than 6 months
  • Any medical condition (including active, clinically significant infection) that, in the opinion of the investigator or sponsor, may pose a safety risk to the participant in this study, which may confound safety or efficacy assessments and jeopardise the quality of data, or may interfere with study participation
  • Presence of cardiac arrhythmias or conduction defects that require immediate treatment
  • QT interval corrected by the Fridericia method (QTcF) > 550 msec
  • History of QT prolongation associated with other medications that required discontinuation of that medication
  • Congenital long QT syndrome
  • Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participant with atrial fibrillation controlled by medication is permitted.
  • History of alcohol or drug abuse within 2 years prior to screening
  • Ongoing treatment with any K-binder before current ED visit/hospital admission. Note: Initiation of any K-binder therapy (including SZC) during the current ED visit/hospital admission is allowed.
  • Chronic haemodialysis or peritoneal dialysis or the recipient of or scheduled date for a kidney transplant.
  • Participation in another clinical study with an investigational product (IP) administered during the month before screening. Note: Participant vaccinated with COVID-19 vaccine whilst still under Emergency Use Utilisation will not be excluded from the study.
  • Known hypersensitivity to SZC or any of the excipients of the product
  • 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 randomisation in the present study
  • For women only: Women of child-bearing potential (WOCBP; ie, those who are not chemically or surgically sterilised or who are not post-menopausal) who are not willing to use one of the methods of contraception described hereafter, from the time of signing the informed consent throughout the study and 4 weeks thereafter: (a) Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal (b) Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable (c) Intrauterine device (IUD) (d) Intrauterine hormone-releasing system (IUS) (e) Bilateral tubal occlusion (f) Vasectomised partner (vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP participant and that the vasectomised partner has received medical assessment of the surgical success (g) Sexual abstinence: it is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.
  • For WOCBP only: Women who have a positive pregnancy test at screening OR women who are breastfeeding.

Sites / Locations

  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sodium Zirconium Cyclosilicate (SZC)

Local standard of care (SoC)

Arm Description

Participants discharged with SZC, as per local label, to manage HK until the end of the outpatient phase

Participants discharged with SoC, as per local practice, to manage HK until the end of study.

Outcomes

Primary Outcome Measures

Occurrence (yes/no) of normokalaemia (NK) (potassium [K+] between 3.5 and 5.0 mmol/L, inclusive)
To evaluate the efficacy of continuing SZC as part of the discharge medications, compared to SoC, in maintaining NK

Secondary Outcome Measures

Time to first occurrence of hospital admissions or ED visits with HK as a contributing factor, all-cause death, or use of rescue therapy for HK
To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the incidence of the composite outcome of hospital admissions or ED visits with HK as a contributing factor, all-cause death, or use of rescue therapy for HK
Time to first occurrence of hospital admission or ED visit, both with HK as a contributing factor
To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the incidence of hospital admissions or ED visit with HK as a contributing factor
Number of hospital admission or ED visits, both with HK as a contributing factor
To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the number of hospital admission or ED visits with HK as a contributing factor
Time to first occurrence of RAASi down-titration (or discontinuation)
To evaluate the effect of continuing SZC as part of the discharge medications compared to SoC on reducing the risk of RAASi down-titration (or discontinuation)

Full Information

First Posted
February 23, 2022
Last Updated
October 4, 2023
Sponsor
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT05347693
Brief Title
Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge Study
Acronym
CONTINUITY
Official Title
An Open-Label, Randomised, Phase 4 Study of Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge in Participants With Chronic Kidney Disease Treated for Hyperkalaemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
October 23, 2024 (Anticipated)
Study Completion Date
October 23, 2024 (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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open-label, randomised study in participants with chronic kidney disease (CKD) treated for hyperkalaemia (HK) whilst in hospital. The study will compare SZC to standard of care (SoC) with the goal of determining: If continued use of SZC maintains normokalaemia (NK) better than SoC after participant discharge from the hospital. If continued use of SZC after discharge will reduce HK related healthcare resource utilisation compared to SoC.
Detailed Description
This is a Phase 4, randomised, controlled, open-label, parallel-group, multicentre study in participants with CKD treated for HK whilst in hospital. Participants from 30 to 50 sites in 4 to 7 countries will be screened for enrolment. In total, 632 participants will be screened to yield 506 participants entering the inpatient phase, resulting in 430 participants discharged and randomised (215 per arm) and 344 evaluable participants. The study plans to enrol approximately equal numbers of participants with mild HK (K+ between > 5.0 and ≤ 5.5 mmol/L) and with moderate/severe HK (K+ between > 5.5 and ≤ 6.5 mmol/L), with a minimum of 30% of the enrolled participants in either group. During the in-hospital phase, participants will be treated with SZC as per local label, starting at baseline and based on local K+ measurement obtained within 24 hours of treatment initiation:). Participants treated with a K-binder other than SZC, at ED visit/hospital admission will be switched to correction treatment with SZC if they are still HK. Such a therapy modification must be based on the investigator's medical judgement of the participant's best interest. Participants who received any K-binder, including SZC at ED visit/hospital admission and are NK at baseline can directly start the maintenance dose of SZC. Participants who initiated SZC during ED visit/hospital admission and are still HK will continue on SZC correction dose (up to 72 hours). All other participants will start correction treatment with SZC as per local label. At discharge, NK participants who have been treated with SZC for between 2 and 21 days whilst in hospital and are established on SZC maintenance dose will be randomised in a 1:1 ratio to one of the following arms: Arm A: Participants discharged with SZC, as per local label, to manage HK until the end of the outpatient phase Arm B: Participants discharged with SoC, as per local practice, to manage HK until the end of study. Note: Participants intended to be discharged with a K+ binder (as per the site routine medical practice) will not be randomised and will be discontinued from the study. Still, participants randomised into Arm B may have a K-binder prescribed at, or after Day 7 post-discharge, to treat confirmed HK or in case there is an increase in K+ level since discharge that, in the investigator's opinion, requires therapy. The total duration of the study for each participant will be up to approximately 189 days, with a maximum of 208 days. Study visit schedule is as follows: In-hospital phase: - The screening visit will occur while the participant is at the hospital (up to 21 days before discharge; medical monitor's approval may be sought for allowing longer duration hospital stays for specific participants) in order to check eligibility criteria Inpatient phase: o The baseline visit (can occur the same day as the screening visit) where correction treatment with SZC will be initiated o The discharge visit, 1 to 20 days after baseline; medical monitor's approval may be sought for allowing longer duration hospital stays for specific participants). Randomisation will occur at day of discharge. Outpatient phase: - Visits will occur at 7, 30, 60, 90, 120, 150, and 180 (EOT, End of Trial) days after randomisation. Only visits at 7, 90 and 180 days after randomisation will be on-site visits, the remaining being telephone visits. If dose titration occurs at any time during the outpatient phase, unscheduled dispensation visits will be performed. Follow-up phase: - A follow-up on-site visit (end of study visit) will occur approximately 7 days after EOT. • Data will be collected at on-site visits, via telephone visits and medical chart reviews. • An adjudication committee will be involved in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperkalaemia, Chronic Kidney Disease
Keywords
sodium zirconium cyclosilicate, Hyperkalaemia after discharge at the hospital

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This is a Phase 4, randomised, controlled, open-label, parallel-group, multicentre study in participants with CKD treated for HK whilst in hospital. During the in-hospital phase, participants will be treated with SZC as per local label At discharge, NK participants who have been treated with SZC for between 2 and 21 days whilst in hospital and are established on SZC maintenance dose will be randomised in a 1:1 ratio to one of the following arms: Arm A: Participants discharged with SZC, as per local label, to manage HK until the end of the outpatient phase Arm B: Participants discharged with SoC, as per local practice, to manage HK until the end of study. Note: Participants intended to be discharged with a K+ binder (as per the site routine medical practice) will not be randomised and will be discontinued from the study. The total duration of the study for each participant will be up to approximately 189 days, with a maximum of 208 days.
Masking
None (Open Label)
Masking Description
No Masking
Allocation
Randomized
Enrollment
432 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sodium Zirconium Cyclosilicate (SZC)
Arm Type
Experimental
Arm Description
Participants discharged with SZC, as per local label, to manage HK until the end of the outpatient phase
Arm Title
Local standard of care (SoC)
Arm Type
Active Comparator
Arm Description
Participants discharged with SoC, as per local practice, to manage HK until the end of study.
Intervention Type
Drug
Intervention Name(s)
Sodium Zirconium Cyclosilicate (SZC)
Other Intervention Name(s)
Lokelma
Intervention Description
White to grey crystalline powder for oral suspension in 5 g sachets. Each sachet will be labeled in accordance with Good Manufacturing Practice Annex 13 and per country regulatory requirement. Label text will be translated into local language.
Intervention Type
Drug
Intervention Name(s)
Local standard of care
Other Intervention Name(s)
SoC
Intervention Description
Local SoC in the country to be used as per local label
Primary Outcome Measure Information:
Title
Occurrence (yes/no) of normokalaemia (NK) (potassium [K+] between 3.5 and 5.0 mmol/L, inclusive)
Description
To evaluate the efficacy of continuing SZC as part of the discharge medications, compared to SoC, in maintaining NK
Time Frame
Up to 180 days post-discharge
Secondary Outcome Measure Information:
Title
Time to first occurrence of hospital admissions or ED visits with HK as a contributing factor, all-cause death, or use of rescue therapy for HK
Description
To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the incidence of the composite outcome of hospital admissions or ED visits with HK as a contributing factor, all-cause death, or use of rescue therapy for HK
Time Frame
Up to 180 days post-discharge
Title
Time to first occurrence of hospital admission or ED visit, both with HK as a contributing factor
Description
To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the incidence of hospital admissions or ED visit with HK as a contributing factor
Time Frame
Up to 180 days post-discharge
Title
Number of hospital admission or ED visits, both with HK as a contributing factor
Description
To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the number of hospital admission or ED visits with HK as a contributing factor
Time Frame
Up to 180 days post-discharge
Title
Time to first occurrence of RAASi down-titration (or discontinuation)
Description
To evaluate the effect of continuing SZC as part of the discharge medications compared to SoC on reducing the risk of RAASi down-titration (or discontinuation)
Time Frame
Up to 180 days post-discharge
Other Pre-specified Outcome Measures:
Title
Adverse Events (AE)
Description
Assessments related to AEs cover: Occurrence/frequency, Relationship to SZC as assessed by investigator, Intensity, Seriousness, Death, AEs leading to discontinuation of SZC.
Time Frame
From time of signature of the ICF, throughout the treatment period and including the follow-up period, 201 days maximum
Title
Weight in kilograms
Description
Weight will be measured using the same scale and in the same state of dress as part of vital signs
Time Frame
From time of signature of the ICF, throughout the treatment period and including the follow-up period, 201 days maximum
Title
Height in centimeters
Description
Height will be measured as part of vital signs.
Time Frame
Height will be measured at screening visit
Title
Blood pressure (BP) in mmHg
Description
Blood pressure should be measured with a completely automated device in triplicate with at least 1-minute intervals between measurements after being comfortably at rest in a seated position with the back and feet supported quietly for at least 5 minutes. Manual techniques will be used only if an automated device is not available. The same device should preferably be used for the participant during the course of the study and in the same arm.
Time Frame
From time of signature of the ICF, throughout the treatment period and including the follow-up period, 201 days maximum
Title
Pulse rate in beats/min
Description
Pulse rate should be measured with a completely automated device in triplicate with at least 1-minute intervals between measurements after being comfortably at rest in a seated position with the back and feet supported quietly for at least 5 minutes. Manual techniques will be used only if an automated device is not available. The same device should preferably be used for the participant during the course of the study and in the same arm.
Time Frame
From time of signature of the ICF, throughout the treatment period and including the follow-up period, 201 days maximum
Title
Clinical safety laboratory tests
Description
Serum electrolytes values（mmol/L), serum BUN（mmol/L), urinalysis and others
Time Frame
From time of signature of the ICF, throughout the treatment period and the follow-up period, 201 days maximum
Title
Electrocardiograms (ECG)
Description
An ECG will be performed throughout study participation and according to clinical judgment in connection with severe hypokalaemia (K+ < 3.0 mmol/L), severe HK (K+ > 6.0 mmol/L), or any symptoms or clinical events suggesting cardiac arrhythmia.
Time Frame
From time of signature of the ICF, throughout the treatment period and the follow-up period, 201 days maximum
Title
Time to first occurrence of any component of hospital admission or ED visit, both with HK as a contributing factor, or all-cause death
Description
To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the incidence of the composite outcome of hospital admissions or ED visits with HK as a contributing factor or all-cause death
Time Frame
Up to 180 days post-discharge
Title
Time to first occurrence of either hospital admission with HK as a contributing factor or allcause death
Description
To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the incidence of hospital admissions with HK as a contributing factor or all-cause death
Time Frame
Up to 180 days post-discharge
Title
Time to first occurrence of either ED visit with HK as a contributing factor or all-cause death
Description
To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the incidence of ED visits with HK as a contributing factor or all-cause death
Time Frame
Up to 180 days post-discharge
Title
Time to first occurrence of any component of all-cause hospitalisations, ED visits, use of rescue therapy for HK or all-cause death in each arm
Description
To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the incidence of the composite outcome of all-cause hospitalisations, ED visits, all cause death, or use of rescue therapy for HK
Time Frame
Up to 180 days post-discharge
Title
K+ level
Description
To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, on mean K+ levels
Time Frame
Up to 180 days post-discharge
Title
Number of hospital admissions with HK as a contributing factor
Description
To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the number of hospital admissions with HK as a contributing factor
Time Frame
Up to 180 days post-discharge
Title
Time to first occurrence of K-binder use in each arm
Description
To evaluate the effect of continuing SZC as part of discharge medications, compared to SoC in reducing the incidence of K-binder use
Time Frame
Up to 180 days post-discharge
Title
Frequency of the use of K-binder to treat HK in each arm
Description
To evaluate the effect of continuing SZC as part of discharge medications, compared to SoC in reducing the frequency and duration of K-binder use
Time Frame
Up to 180 days post-discharge
Title
Time to first occurrence of rescue therapy use in each arm
Description
To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the incidence of rescue therapy for HK use
Time Frame
up to 180 days post-discharge
Title
Time to first occurrence of all-cause hospitalisations, ED visits, or outpatient visits in each arm
Description
To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the incidence of the composite outcome of all-cause hospitalisations, ED visits, or outpatient visits
Time Frame
up to 180 days post-discharge
Title
Rate of change in (slope) eGFR (estimated glomerular filtration rate) from inpatient phase
Description
To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in the change in eGFR
Time Frame
90 and 180 days post-discharge
Title
Time to first occurrence of dialysis initiation in each arm
Description
To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in the incidence of dialysis initiation
Time Frame
up to 180 days post-discharge
Title
Time to first occurrence of ICU (intensive care unit) admissions in each arm
Description
To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the incidence of ICU admissions
Time Frame
up to 180 days post-discharge
Title
Frequency (%) of participants on RAASi (renin-angiotensin-aldosterone system inhibitor) at discharge who remained on / increased / decreased / initiated RAASi
Description
This exploratory endpoint will descriptively summarise the use of RAASi in each treatment arm
Time Frame
90 and 180 days post-discharge

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: Must be 18 years of age or older, at the time of signing the informed consent Admitted to hospital (inpatient care; directly or from ED) With: diagnosed stage 3b to 5 CKD And/or eGFR < 45 ml/min/1.73 m2 at, or within 3 months of, study screening, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Levey et al, 2009). Note: Race/ethnicity should not be included in CKD-EPI equation calculation. Hyperkalaemia at current ED visit/hospital admission as defined by site's local practice and K+ must be between > 5.0 and ≤ 6.5 mmol/L. Male or female Capable and willing of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: Myocardial infarction, stroke, seizure, or a thrombotic/thromboembolic event (eg, deep vein thrombosis or pulmonary embolism, but excluding vascular access thrombosis) within 12 weeks prior to screening Unable to take oral SZC drug mix With a life expectancy of less than 6 months Any medical condition (including active, clinically significant infection) that, in the opinion of the investigator or sponsor, may pose a safety risk to the participant in this study, which may confound safety or efficacy assessments and jeopardise the quality of data, or may interfere with study participation Presence of cardiac arrhythmias or conduction defects that require immediate treatment QT interval corrected by the Fridericia method (QTcF) > 550 msec History of QT prolongation associated with other medications that required discontinuation of that medication Congenital long QT syndrome Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participant with atrial fibrillation controlled by medication is permitted. History of alcohol or drug abuse within 2 years prior to screening Ongoing treatment with any K-binder before current ED visit/hospital admission. Note: Initiation of any K-binder therapy (including SZC) during the current ED visit/hospital admission is allowed. Chronic haemodialysis or peritoneal dialysis or the recipient of or scheduled date for a kidney transplant. Participation in another clinical study with an investigational product (IP) administered during the month before screening. Note: Participant vaccinated with COVID-19 vaccine whilst still under Emergency Use Utilisation will not be excluded from the study. Known hypersensitivity to SZC or any of the excipients of the product 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 randomisation in the present study For women only: Women of child-bearing potential (WOCBP; ie, those who are not chemically or surgically sterilised or who are not post-menopausal) who are not willing to use one of the methods of contraception described hereafter, from the time of signing the informed consent throughout the study and 4 weeks thereafter: (a) Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal (b) Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable (c) Intrauterine device (IUD) (d) Intrauterine hormone-releasing system (IUS) (e) Bilateral tubal occlusion (f) Vasectomised partner (vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP participant and that the vasectomised partner has received medical assessment of the surgical success (g) Sexual abstinence: it is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant. For WOCBP only: Women who have a positive pregnancy test at screening OR women who are breastfeeding.
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
Facility Information:
Facility Name
Research Site
City
Belgium
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Dendermonde
ZIP/Postal Code
9200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lodelinsart
ZIP/Postal Code
6042
Country
Belgium
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Annonay
ZIP/Postal Code
07103
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ars-Laquenexy
ZIP/Postal Code
57530
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
La Tronche
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Saint-priest En Jarez
ZIP/Postal Code
42270
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kaiserslautern
ZIP/Postal Code
67655
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Acireale
ZIP/Postal Code
95024
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Bari
ZIP/Postal Code
70120
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Foggia
ZIP/Postal Code
71122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Parma
ZIP/Postal Code
43125
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Terminated
Facility Name
Research Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00163
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1105AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Eindhoven
ZIP/Postal Code
5602 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Almería
ZIP/Postal Code
04009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Badajoz
ZIP/Postal Code
06080
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Burgos
ZIP/Postal Code
9006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Getafe
ZIP/Postal Code
28905
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
Palma de Mallorca
ZIP/Postal Code
7120
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
San Sebastián de los Reyes
ZIP/Postal Code
28702
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Individual Site Status
Suspended
Facility Name
Research Site
City
Doncaster
ZIP/Postal Code
DN2 5LT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hull
ZIP/Postal Code
HU10 7AZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Individual Site Status
Suspended
Facility Name
Research Site
City
London
ZIP/Postal Code
6BQ
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
Stevenage
ZIP/Postal Code
SG1 4AB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
York
ZIP/Postal Code
YO31 8HE
Country
United Kingdom
Individual Site Status
Withdrawn

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 deidentified 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

Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge Study

We'll reach out to this number within 24 hrs