A Study to Investigate the Effects of Zibotentan/Dapagliflozin Combination Compared to Dapagliflozin Alone in Adult Participants With Chronic Kidney Disease and High Proteinuria

Recruiting now · Phase 2

Conditions studied: Chronic Kidney Disease With High Proteinuria

In brief

A Study to Investigate the Effects of Zibotentan/Dapagliflozin Combination Compared to Dapagliflozin Alone in Adult Participants with Chronic Kidney Disease and High Proteinuria

Key facts

Study ID

NCT06942910

Run by

AstraZeneca

People needed

224

Starts

2025-05-07

Expected to finish

2026-07-31

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years of age at the time of signing the informed consent.
• Diagnosis of CKD with eGFR ≥ 20 and < 90 mL/min/1.73m2 AND UACR > 700 mg/g (> 79 mg/mmol) or UPCR > 1000 mg/g (> 113 mg/mmol).
• Body mass index (BMI) within the range ≤40 kg/m2.
• Female participants must be either - not of child-bearing potential or - women of childbearing potential (WOCBP) using at least one highly effective birth control method for at least 3 months prior to first dose of study intervention.
• All WOCBP must have a negative serum pregnancy test result at screening.
• Receiving RAASi therapy (ACEi or ARB), and for the patient maximum tolerated labelled daily dose, that has been stable for at least 4 weeks.

You may not qualify if…

• Clinically significant, unstable, or uncontrolled medical condition which in the Investigator's opinion makes it undesirable for the participant to participate in the study.
• Known hypersensitivity to dapagliflozin or zibotentan or any of the excipients of the investigational product. History or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2i therapy or ERAs.
• NYHA class III or class IV HF.
• Participants hospitalised for HF and/or who have not been stable on HF therapy during the last 6 months prior to screening.
• HF due to cardiomyopathies that would primarily require other specific treatment.
• High output HF (eg, due to hyperthyroidism or Paget's disease).
• HF due to primary cardiac valvular disease/dysfunction, severe functional mitral or tricuspid valve insufficiency, or planned cardiac valve repair/replacement.
• Evidence of rales or jugular venous distention on physical examination.
• Type 1 diabetes mellitus.
• History of any life-threatening ventricular dysrhythmia (continuous or paroxysmal).
• 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.
• Any condition with a life expectancy of less than 1 year 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.
• Renal replacement therapy or previous kidney transplant.
• Known history of significant drug or alcohol abuse within 12 months of screening.
• On treatment with strong or moderate CYP3A4 inducer.
• On systemic immunosuppression therapy other than prespecified stable maintenance therapy.
• Participants treated or expecting to be treated with tolvaptan (including as part of participation in a clinical trial), any other ERAs, or budesonide (where used to treat IBD or IgAN).
• Systolic blood pressure above 160 mmHg and/or below 90 mmHg.
• Significant impairment of liver function defined as AST or ALT >3 x upper limit of normal (ULN) or Total serum bilirubin >2 x ULN (an isolated increase in bilirubin in participants with known Gilbert's syndrome is not a reason for exclusion).
• NT-proBNP ≥ 600 pg/mL (or NT-proBNP ≥ 1200 pg/mL, if associated with atrial fibrillation) measured by local laboratory at screening.
• Any of the following results of echocardiography at screening:
• left ventricular ejection fraction (LVEF) < 50%

Where it is running

• Research Site — Yaroslavl, Russia (enrolling)
• Research Site — Saratov, Russia (enrolling)
• Research Site — Ulyanovsk, Russia (enrolling)
• Research Site — Aramil, Russia (enrolling)
• Research Site — Krasnoyarsk, Russia (enrolling)
• Research Site — Moscow, Russia (enrolling)
• Research Site — Moscow, Russia (enrolling)
• Research Site — Moscow, Russia (enrolling)
• Research Site — Omsk, Russia (enrolling)
• Research Site — Orenburg, Russia (enrolling)
• Research Site — Perm, Russia (enrolling)
• Research Site — Saratov, Russia (enrolling)
• Research Site — Izhevsk, Russia
• Research Site — Saint Petersburg, Russia
• Research Site — Moscow, Russia

Full record on ClinicalTrials.gov

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