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

• Chronic Kidney Disease With High Proteinuria

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zibotentan/Dapagliflozin — DRUG
  Participants will receive zibotentan/dapagliflozin in fixed-dose combination as per the arms they are randomized to
• Dapagliflozin — DRUG
  Participants will receive monotherapy dapagliflozin as per the arms they are randomized to

Study Details

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 Dates

First listed

Apr 24, 2025

Start date

May 7, 2025

Status verified

Aug 2026

Primary completion

Sep 26, 2026

Completion

Sep 26, 2026

Study Design

Enrollment

224 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Zibotentan/Dapagliflozin dose A or Zibotentan/Dapagliflozin dose B
  Drug dose is 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.

Primary Outcome Measure

Change in log-transformed Urinary Albumin to Creatinine Ratio (UACR) from baseline [ Time Frame: At Week 12 ]