RecruitingPhase 2NCT06942910

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

A Multicentre, Randomised, Double-blind, Active-Controlled, 2-arm Parallel-group Treatment, Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin Alone in Adult Participants With Chronic Kidney Disease and High Proteinuria


Sponsor

AstraZeneca

Enrollment

224 participants

Start Date

May 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a combination of two drugs — zibotentan and dapagliflozin — reduces protein in the urine and slows kidney function decline better than dapagliflozin alone in adults with chronic kidney disease (CKD) and high levels of protein leaking into the urine. **You may be eligible if...** - You are 18 or older - You have CKD with a moderately reduced kidney filtration rate (eGFR 20–89) AND significantly elevated urinary protein levels (UACR over 700 mg/g) - Your BMI is 40 or below - You are already on a stable dose of an ACE inhibitor or ARB blood pressure/kidney medication **You may NOT be eligible if...** - You have severe heart failure (NYHA Class III or IV) - You have had a recent hospitalisation for heart-related reasons - You are allergic to dapagliflozin or related drugs - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZibotentan/Dapagliflozin

Participants will receive zibotentan/dapagliflozin in fixed-dose combination as per the arms they are randomized to

DRUGDapagliflozin

Participants will receive monotherapy dapagliflozin as per the arms they are randomized to


Locations(15)

Research Site

Aramil, Russia

Research Site

Izhevsk, Russia

Research Site

Krasnoyarsk, Russia

Research Site

Moscow, Russia

Research Site

Moscow, Russia

Research Site

Moscow, Russia

Research Site

Moscow, Russia

Research Site

Omsk, Russia

Research Site

Orenburg, Russia

Research Site

Perm, Russia

Research Site

Saint Petersburg, Russia

Research Site

Saratov, Russia

Research Site

Saratov, Russia

Research Site

Ulyanovsk, Russia

Research Site

Yaroslavl, Russia

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NCT06942910