Actively Recruiting
A Study to Investigate the Effects of Zibotentan/Dapagliflozin Combination Compared to Dapagliflozin Alone in Adult Participants With Chronic Kidney Disease and High Proteinuria
Led by AstraZeneca · Updated on 2026-04-17
224
Participants Needed
15
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Study to Investigate the Effects of Zibotentan/Dapagliflozin Combination Compared to Dapagliflozin Alone in Adult Participants with Chronic Kidney Disease and High Proteinuria
CONDITIONS
Official Title
A Study to Investigate the Effects of Zibotentan/Dapagliflozin Combination Compared to Dapagliflozin Alone in Adult Participants With Chronic Kidney Disease and High Proteinuria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at the time of signing informed consent
- Diagnosis of chronic kidney disease with estimated glomerular filtration rate (eGFR) between 20 and less than 90 mL/min/1.73m2
- Urinary albumin to creatinine ratio (UACR) greater than 700 mg/g or urinary protein to creatinine ratio (UPCR) greater than 1000 mg/g
- Body mass index (BMI) less than or equal to 40 kg/m2
- Female participants must either not be of childbearing potential or use at least one highly effective birth control method for at least 3 months prior to first dose
- All women of childbearing potential must have a negative serum pregnancy test at screening
- Receiving stable renin-angiotensin-aldosterone system inhibitor (RAASi) therapy, either ACE inhibitor or angiotensin receptor blocker, at maximum tolerated labeled daily dose for at least 4 weeks
You will not qualify if you...
- Clinically significant, unstable, or uncontrolled medical condition making participation undesirable
- Known allergy or hypersensitivity to dapagliflozin, zibotentan, or related therapies
- New York Heart Association (NYHA) class III or IV heart failure
- Hospitalization for heart failure or unstable heart failure treatment within 6 months prior to screening
- Heart failure due to cardiomyopathies requiring specific treatments
- High output heart failure caused by conditions like hyperthyroidism or Paget's disease
- Heart failure due to primary valvular disease or severe valve dysfunction
- Physical signs of heart failure such as rales or jugular venous distention
- Type 1 diabetes mellitus
- History of life-threatening ventricular arrhythmias
- Hospitalization for heart disease, cardiac procedures, or COVID-19 within 3 months prior to screening
- History of solid organ or bone marrow transplantation
- Life expectancy less than 1 year as judged by investigator
- Cancer within past 5 years except non-melanoma skin cancer or treated cervical carcinoma in situ
- Significant liver disease
- Renal replacement therapy or prior kidney transplant
- History of significant drug or alcohol abuse within 12 months
- Use of strong or moderate CYP3A4 inducers
- Use of systemic immunosuppressive therapy except stable maintenance
- Treatment or planned treatment with tolvaptan, other ERAs, or budesonide for certain diseases
- Systolic blood pressure above 160 mmHg or below 90 mmHg
- Significant liver function impairment defined by elevated AST, ALT, or bilirubin
- Elevated NT-proBNP levels above defined thresholds
- Echocardiography showing left ventricular ejection fraction below 50%, significant wall motion or valve abnormalities, or isolated pulmonary arterial hypertension
- Pregnant, breastfeeding, or unwilling/unable to use adequate contraception if of childbearing potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Research Site
Aramil, Russia, 624002
Actively Recruiting
2
Research Site
Izhevsk, Russia, 426061
Suspended
3
Research Site
Krasnoyarsk, Russia, 660062
Actively Recruiting
4
Research Site
Moscow, Russia, 105554
Suspended
5
Research Site
Moscow, Russia, 111539
Actively Recruiting
6
Research Site
Moscow, Russia, 117036
Actively Recruiting
7
Research Site
Moscow, Russia, 129327
Actively Recruiting
8
Research Site
Omsk, Russia, 644112
Actively Recruiting
9
Research Site
Orenburg, Russia, 460018
Actively Recruiting
10
Research Site
Perm, Russia, 614000
Actively Recruiting
11
Research Site
Saint Petersburg, Russia, 195067
Suspended
12
Research Site
Saratov, Russia, 410053
Actively Recruiting
13
Research Site
Saratov, Russia, 410054
Actively Recruiting
14
Research Site
Ulyanovsk, Russia, 432009
Actively Recruiting
15
Research Site
Yaroslavl, Russia, 150062
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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