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

Sponsor
AstraZeneca
Study ID
NCT06942910
Phase
PHASE2
Status
Recruiting
Apply to this trial

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

Start date
May 7, 2025
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
224 participants (estimated)
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 ]

Central Contacts