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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06087835




Registration number
NCT06087835
Ethics application status
Date submitted
4/10/2023
Date registered
18/10/2023

Titles & IDs
Public 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)
Scientific 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
Secondary ID [1] 0 0
D4325C00010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease With High Proteinuria 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zibotentan/Dapagliflozin
Treatment: Drugs - Dapagliflozin

Experimental: Zibotentan/Dapagliflozin dose A or Zibotentan/Dapagliflozin dose B - 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.

Active comparator: Dapagliflozin alone - Participants will receive daily oral dose of dapagliflozin.


Treatment: Drugs: Zibotentan/Dapagliflozin
Participants will receive zibotentan/dapagliflozin in fixed-dose combination as per the arms they are randomized to

Treatment: Drugs: Dapagliflozin
Participants will receive dapagliflozin as per the arms they are randomized to
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in eGFR from baseline
Timepoint [1] 0 0
At month 24
Secondary outcome [1] 0 0
Change in Urine Protein to Creatinine Ratio (UPCR) from baseline to each participant's mean level
Timepoint [1] 0 0
Across the visits from Day 15 up to Month 24
Secondary outcome [2] 0 0
Change in UACR from baseline to each participant's mean level
Timepoint [2] 0 0
Across the visits from Day 15 up to Month 24
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Through study completion, approximately 43 months
Secondary outcome [4] 0 0
Change in systolic blood pressure from baseline to each participant's mean level
Timepoint [4] 0 0
Across the visits from Day 15 up to Month 24
Secondary outcome [5] 0 0
Proportion of participants achieving Urine Protein to Creatinine Ratio (UPCR) < 1000 mg/g and > 30% reduction from baseline for each participant's mean level
Timepoint [5] 0 0
Across the visits from Day 15 up to Month 24

Eligibility
Key inclusion criteria
1. 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.
2. 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).
3. All female participants must have a negative serum pregnancy test result at screening.
4. 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
5. Capable of giving signed informed consent
6. Provision of signed informed consent prior to any study specific procedure.
7. Provision of electronic informed consent prior to completion of the optional Study Participant Feedback Questionnaire (SPFQ).
8. 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.
9. Receiving RAASi therapy (ACEi or ARB), and for the patient maximum tolerated labelled daily dose, that has been stable for at least 4 weeks.
Minimum age
18 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants with NYHA class III or class IV Congestive HF at the time of enrolment.
2. Participants hospitalised for HF during the last 6 month prior to screening.
3. Evidence of rales or jugular venous distention on physical examination.
4. Participants with type 1 diabetes mellitus.
5. History of any life-threatening ventricular dysrhythmia (continuous or paroxysmal).
6. Blood pressure above 160 mmHg systolic.
7. Blood pressure below 90 mmHg systolic.
8. Participants hospitalised for heart disease or cardiac procedures or for COVID-19 during the last 3 months prior to screening.
9. History of solid organ transplantation or bone marrow transplant.
10. 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).
11. Any condition with a life expectancy of less than 2 years based on investigator´s clinical judgment.
12. Malignancy within the past 5 years. Exceptions to this criterion include non-melanoma skin cancer and curatively treated cervical carcinoma in situ.
13. 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.
14. Known blood-borne diseases.
15. Clinically significant, unstable, or uncontrolled medical condition as assessed by the Investigator.
16. Participants on renal replacement therapy or previous kidney transplant.
17. Known history of drug or alcohol abuse within 12 months of screening.
18. Participants on treatment with strong or moderate CYP3A4 inducer.
19. 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.
20. Participants treated or expecting to be treated with tolvaptan, any other ERAs, or budesonide (where used to treat IBD or IgAN).
21. Participation in another clinical study with a study intervention administered in the last 3 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Gosford
Recruitment hospital [2] 0 0
Research Site - Meadowbrook
Recruitment hospital [3] 0 0
Research Site - Perth
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Research Site - Reservoir
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Research Site - Southport
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2250 - Gosford
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4131 - Meadowbrook
Recruitment postcode(s) [3] 0 0
6000 - Perth
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3021 - Reservoir
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3073 - Reservoir
Recruitment postcode(s) [6] 0 0
4222 - Southport
Recruitment outside Australia
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Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06087835