search
Back to results

Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants With Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria)

Primary Purpose

Chronic Kidney Disease With High Proteinuria

Status
Not yet recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Zibotentan/Dapagliflozin
Dapagliflozin
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease With High Proteinuria focused on measuring Zibotentan, Nephrology, Dapagliflozin, Sodium-glucose co-transporter 2, sodium-glucose co-transporter 2 inhibitor, Kidney diseases, Endothelin antagonist, High Proteinuria

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participant must be ≥ 18 years of age and of legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent. Diagnosis of CKD, defined as eGFR ≥ 20 and < 90 mL/min/1.73 m2 and UACR > 700 mg/g (> 79 mg/mmol) or UPCR > 1000 mg/g (> 113 mg/mmoL). All female participants must have a negative serum pregnancy test result at screening. Female participants must be either not of child-bearing potential or women of child bearing potential (WOCBP) using at least one highly effective birth control method for at least 3 months prior to first dose of study intervention Capable of giving signed informed consent Provision of signed informed consent prior to any study specific procedure. Provision of electronic informed consent prior to completion of the optional Study Participant Feedback Questionnaire (SPFQ). Provision of signed and dated written Optional Genomics Initiative Research Information and Consent Form prior to collection of samples for optional genomics imitative research that supports the Genomic Initiative 5. Receiving RAASi therapy (ACEi or ARB), and for the patient maximum tolerated labelled daily dose, that has been stable for at least 4 weeks. Exclusion Criteria: Participants with NYHA class III or class IV Congestive HF at the time of enrolment. Participants hospitalised for HF during the last 6 month prior to screening. Evidence of rales or jugular venous distention on physical examination. Participants with type 1 diabetes mellitus. History of any life-threatening ventricular dysrhythmia (continuous or paroxysmal). Blood pressure above 160 mmHg systolic. Blood pressure below 90 mmHg systolic or 60 mmHg diastolic. Participants hospitalised for heart disease or cardiac procedures or for COVID-19 during the last 3 months prior to screening. History of solid organ transplantation or bone marrow transplant. History or ongoing allergy/hypersensitivity, as judged by the Investigator, to SGLT2i therapy (eg, dapagliflozin, canagliflozin, empagliflozin or other SGLT2 inhibitors) or Endothelin Receptor Antagonists (eg, ambrisentan, atrasentan, bosentan, or other). Any condition with a life expectancy of less than 2 years based on investigator´s clinical judgment. Malignancy within the past 5 years. Exceptions to this criterion include non-melanoma skin cancer and curatively treated cervical carcinoma in situ. Significant liver disease as judged by the investigator or severe hepatic impairment with AST or ALT > 3 × ULN; or total bilirubin > 2 × ULN at time of screening. An isolated increase in bilirubin in participants with known Gilbert's syndrome is not a reason for exclusion. Known blood-borne diseases. Clinically significant, unstable, or uncontrolled medical condition as assessed by the Investigator. Participants on renal replacement therapy or previous kidney transplant. Known history of drug or alcohol abuse within 12 months of screening. Participants on treatment with strong or moderate CYP3A4 inducer. Participants on systemic immunosuppression therapy other than stable maintenance therapy defined as prednisone 10 mg/day (or equivalent) or less, aziothioprine 100 mg/day or less; MMF 1000 mg/day or less for at least 3 months prior to Visit 1. Inhaled, nasal or dermatological steroids are also allowed. Participants treated or expecting to be treated with tolvaptan, any other ERAs, or budesonide (where used to treat IBD or IgAN). Participation in another clinical study with a study intervention administered in the last 3 months.

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Zibotentan/Dapagliflozin dose A or Zibotentan/Dapagliflozin dose B

Dapagliflozin alone

Arm Description

Drug dose (dose A or B) are determined based on eGFR values. Participants will receive daily oral dose of zibotentan/dapagliflozin in fixed dose combination.

Participants will receive daily oral dose of dapagliflozin.

Outcomes

Primary Outcome Measures

Change in eGFR from baseline
To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone to slow decline in kidney function

Secondary Outcome Measures

Change in Urine Protein to Creatinine Ratio (UPCR) from baseline to each participant's mean level
To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone in reducing proteinuria
Change in UACR from baseline to each participant's mean level
To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone in reducing albuminuria
Time to the first occurrence of any of the components of the renal composite endpoint of 40% sustained decline in eGFR or ESKD or renal death
To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone in reducing the incidence of the renal composite endpoint of 40% sustained decline in eGFR or ESKD or renal death
Change in systolic blood pressure from baseline to each participant's mean level
To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone in reducing systolic blood pressure
Proportion of participants achieving Urine Protein to Creatinine Ratio (UPCR) < 1000 mg/g and > 30% reduction from baseline for each participant's mean level
To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone, in reducing proteinuria, as measured by the proportion of participants achieving Urine Protein to Creatinine Ratio (UPCR) < 1000 mg/g and > 30% reduction from baseline

Full Information

First Posted
October 4, 2023
Last Updated
October 17, 2023
Sponsor
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT06087835
Brief Title
Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants With Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria)
Official Title
A Phase III, Randomised, Multicentre, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin Alone in Participants With Chronic Kidney Disease and High Proteinuria
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 10, 2023 (Anticipated)
Primary Completion Date
July 5, 2027 (Anticipated)
Study Completion Date
July 5, 2027 (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
This is a Phase III, randomised, multicentre, double-blinded study to evaluate efficacy, safety and tolerability of treatment with zibotentan/dapagliflozin and dapagliflozin alone in participants with chronic kidney disease (CKD) and high proteinuria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease With High Proteinuria
Keywords
Zibotentan, Nephrology, Dapagliflozin, Sodium-glucose co-transporter 2, sodium-glucose co-transporter 2 inhibitor, Kidney diseases, Endothelin antagonist, High Proteinuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zibotentan/Dapagliflozin dose A or Zibotentan/Dapagliflozin dose B
Arm Type
Experimental
Arm Description
Drug dose (dose A or B) are determined based on eGFR values. Participants will receive daily oral dose of zibotentan/dapagliflozin in fixed dose combination.
Arm Title
Dapagliflozin alone
Arm Type
Active Comparator
Arm Description
Participants will receive daily oral dose of dapagliflozin.
Intervention Type
Drug
Intervention Name(s)
Zibotentan/Dapagliflozin
Intervention Description
Participants will receive zibotentan/dapagliflozin in fixed-dose combination as per the arms they are randomized to
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
Participants will receive dapagliflozin as per the arms they are randomized to
Primary Outcome Measure Information:
Title
Change in eGFR from baseline
Description
To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone to slow decline in kidney function
Time Frame
At month 24
Secondary Outcome Measure Information:
Title
Change in Urine Protein to Creatinine Ratio (UPCR) from baseline to each participant's mean level
Description
To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone in reducing proteinuria
Time Frame
Across the visits from Day 15 up to Month 24
Title
Change in UACR from baseline to each participant's mean level
Description
To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone in reducing albuminuria
Time Frame
Across the visits from Day 15 up to Month 24
Title
Time to the first occurrence of any of the components of the renal composite endpoint of 40% sustained decline in eGFR or ESKD or renal death
Description
To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone in reducing the incidence of the renal composite endpoint of 40% sustained decline in eGFR or ESKD or renal death
Time Frame
Through study completion, approximately 43 months
Title
Change in systolic blood pressure from baseline to each participant's mean level
Description
To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone in reducing systolic blood pressure
Time Frame
Across the visits from Day 15 up to Month 24
Title
Proportion of participants achieving Urine Protein to Creatinine Ratio (UPCR) < 1000 mg/g and > 30% reduction from baseline for each participant's mean level
Description
To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone, in reducing proteinuria, as measured by the proportion of participants achieving Urine Protein to Creatinine Ratio (UPCR) < 1000 mg/g and > 30% reduction from baseline
Time Frame
Across the visits from Day 15 up to Month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant must be ≥ 18 years of age and of legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent. Diagnosis of CKD, defined as eGFR ≥ 20 and < 90 mL/min/1.73 m2 and UACR > 700 mg/g (> 79 mg/mmol) or UPCR > 1000 mg/g (> 113 mg/mmoL). All female participants must have a negative serum pregnancy test result at screening. Female participants must be either not of child-bearing potential or women of child bearing potential (WOCBP) using at least one highly effective birth control method for at least 3 months prior to first dose of study intervention Capable of giving signed informed consent Provision of signed informed consent prior to any study specific procedure. Provision of electronic informed consent prior to completion of the optional Study Participant Feedback Questionnaire (SPFQ). Provision of signed and dated written Optional Genomics Initiative Research Information and Consent Form prior to collection of samples for optional genomics imitative research that supports the Genomic Initiative 5. Receiving RAASi therapy (ACEi or ARB), and for the patient maximum tolerated labelled daily dose, that has been stable for at least 4 weeks. Exclusion Criteria: Participants with NYHA class III or class IV Congestive HF at the time of enrolment. Participants hospitalised for HF during the last 6 month prior to screening. Evidence of rales or jugular venous distention on physical examination. Participants with type 1 diabetes mellitus. History of any life-threatening ventricular dysrhythmia (continuous or paroxysmal). Blood pressure above 160 mmHg systolic. Blood pressure below 90 mmHg systolic or 60 mmHg diastolic. Participants hospitalised for heart disease or cardiac procedures or for COVID-19 during the last 3 months prior to screening. History of solid organ transplantation or bone marrow transplant. History or ongoing allergy/hypersensitivity, as judged by the Investigator, to SGLT2i therapy (eg, dapagliflozin, canagliflozin, empagliflozin or other SGLT2 inhibitors) or Endothelin Receptor Antagonists (eg, ambrisentan, atrasentan, bosentan, or other). Any condition with a life expectancy of less than 2 years based on investigator´s clinical judgment. Malignancy within the past 5 years. Exceptions to this criterion include non-melanoma skin cancer and curatively treated cervical carcinoma in situ. Significant liver disease as judged by the investigator or severe hepatic impairment with AST or ALT > 3 × ULN; or total bilirubin > 2 × ULN at time of screening. An isolated increase in bilirubin in participants with known Gilbert's syndrome is not a reason for exclusion. Known blood-borne diseases. Clinically significant, unstable, or uncontrolled medical condition as assessed by the Investigator. Participants on renal replacement therapy or previous kidney transplant. Known history of drug or alcohol abuse within 12 months of screening. Participants on treatment with strong or moderate CYP3A4 inducer. Participants on systemic immunosuppression therapy other than stable maintenance therapy defined as prednisone 10 mg/day (or equivalent) or less, aziothioprine 100 mg/day or less; MMF 1000 mg/day or less for at least 3 months prior to Visit 1. Inhaled, nasal or dermatological steroids are also allowed. Participants treated or expecting to be treated with tolvaptan, any other ERAs, or budesonide (where used to treat IBD or IgAN). Participation in another clinical study with a study intervention administered in the last 3 months.
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
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Research Site
City
Chatsworth
State/Province
California
ZIP/Postal Code
91311
Country
United States
Facility Name
Research Site
City
S. Gate
State/Province
California
ZIP/Postal Code
90280
Country
United States
Facility Name
Research Site
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Research Site
City
Victorville
State/Province
California
ZIP/Postal Code
92395
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States
Facility Name
Research Site
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28504
Country
United States
Facility Name
Research Site
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Research Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Research Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76015
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78204
Country
United States
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
C1425AGC
Country
Argentina
Facility Name
Research Site
City
Ciudad de Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Facility Name
Research Site
City
Mar del Plata
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Research Site
City
Mar del Plata
ZIP/Postal Code
B7600
Country
Argentina
Facility Name
Research Site
City
Rosario
ZIP/Postal Code
S2000DSV
Country
Argentina
Facility Name
Research Site
City
Santa Fe
ZIP/Postal Code
S3000
Country
Argentina
Facility Name
Research Site
City
Gosford
ZIP/Postal Code
2250
Country
Australia
Facility Name
Research Site
City
Meadowbrook
ZIP/Postal Code
4131
Country
Australia
Facility Name
Research Site
City
Perth
ZIP/Postal Code
6000
Country
Australia
Facility Name
Research Site
City
Reservoir
ZIP/Postal Code
3021
Country
Australia
Facility Name
Research Site
City
Reservoir
ZIP/Postal Code
3073
Country
Australia
Facility Name
Research Site
City
Southport
ZIP/Postal Code
4222
Country
Australia
Facility Name
Research Site
City
Feldkirch
ZIP/Postal Code
6800
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Research Site
City
Dobrich
ZIP/Postal Code
9300
Country
Bulgaria
Facility Name
Research Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Research Site
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Research Site
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 3Z4
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Research Site
City
Baotou
ZIP/Postal Code
014010
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100035
Country
China
Facility Name
Research Site
City
Linhai
ZIP/Postal Code
318000
Country
China
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210009
Country
China
Facility Name
Research Site
City
XI 'an
ZIP/Postal Code
710077
Country
China
Facility Name
Research Site
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Research Site
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Research Site
City
Gentofte
ZIP/Postal Code
2820
Country
Denmark
Facility Name
Research Site
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Research Site
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Research Site
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Research Site
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Research Site
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Research Site
City
Düsseldorf
ZIP/Postal Code
40210
Country
Germany
Facility Name
Research Site
City
Fulda
ZIP/Postal Code
36043
Country
Germany
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Research Site
City
Köln
ZIP/Postal Code
01279
Country
Germany
Facility Name
Research Site
City
Köln
ZIP/Postal Code
50931
Country
Germany
Facility Name
Research Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Research Site
City
München
ZIP/Postal Code
80336
Country
Germany
Facility Name
Research Site
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Research Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Research Site
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Research Site
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
Research Site
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
161
Country
Italy
Facility Name
Research Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Research Site
City
Viterbo
ZIP/Postal Code
01100
Country
Italy
Facility Name
Research Site
City
Cuautitlán
ZIP/Postal Code
91900
Country
Mexico
Facility Name
Research Site
City
Cuernavaca, MOR
ZIP/Postal Code
62448
Country
Mexico
Facility Name
Research Site
City
Mazatlán
ZIP/Postal Code
82110
Country
Mexico
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Research Site
City
Saltillo
ZIP/Postal Code
25230
Country
Mexico
Facility Name
Research Site
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Facility Name
Research Site
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Facility Name
Research Site
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Research Site
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
Facility Name
Research Site
City
Bodø
ZIP/Postal Code
8073
Country
Norway
Facility Name
Research Site
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
Facility Name
Research Site
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Facility Name
Research Site
City
Tromsø
ZIP/Postal Code
9019
Country
Norway
Facility Name
Research Site
City
Angeles City
ZIP/Postal Code
2009
Country
Philippines
Facility Name
Research Site
City
Benoni
ZIP/Postal Code
1501
Country
South Africa
Facility Name
Research Site
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Research Site
City
Chatsworth
ZIP/Postal Code
4092
Country
South Africa
Facility Name
Research Site
City
Durban
ZIP/Postal Code
4450
Country
South Africa
Facility Name
Research Site
City
Lenasia
ZIP/Postal Code
1827
Country
South Africa
Facility Name
Research Site
City
Midrand
ZIP/Postal Code
1685
Country
South Africa
Facility Name
Research Site
City
Parow
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Research Site
City
Soweto
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Research Site
City
Rättvik
ZIP/Postal Code
79530
Country
Sweden
Facility Name
Research Site
City
Kaohsiung city
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Research Site
City
New Taipei
ZIP/Postal Code
220
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Research Site
City
Taipei City
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
Research Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Research Site
City
Yong Kang City
ZIP/Postal Code
710
Country
Taiwan
Facility Name
Research Site
City
Ho Chi Minh City
ZIP/Postal Code
70000
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam

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 requests 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://vivli.org/

Learn more about this trial

Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants With Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria)

We'll reach out to this number within 24 hrs