CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 542 enrolled
Drug / intervention
Zibotentan +2 moredrug
Likely dose
Dapagliflozin 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04724837
NCT04724837Phase 2Completed

A Phase 2b Multicentre, Randomised, Double-Blind, Active-Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety and Tolerability of Zibotentan and Dapagliflozin in Patients With Chronic Kidney Disease With Estimated Glomerular Filtration Rate (eGFR) ≥ 20 mL/Min/1.73 m^2

AstraZeneca·interventional·Posted Jan 26, 2021·Updated Jul 30, 2024

In Brief

A Phase 2 clinical trial evaluating Zibotentan, Dapagliflozin, and 1 other intervention for Chronic Kidney Disease. Completed, enrolled 542 participants across 164 sites in 19 countries.

Detailed Summary

The purpose of the study is to assess efficacy, safety and tolerability of treatment with zibotentan and dapagliflozin in combination and dapagliflozin 10 mg as monotherapy in participants with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73 m\^2, and urinary albumin to creatinine ratio (UACR) ≥ 150 mg/g and ≤ 5000 mg/g.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Brazil, Bulgaria, Canada, Croatia, Denmark, Georgia, Hungary, Italy, Japan, Malaysia, Netherlands, Poland, Slovakia, South Africa, Spain, Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJan 26, 2021
Enrollment StartApr 28, 2021
Primary CompletionJun 1, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.4 years ago

Interventions

Zibotentandrug

Participants will receive zibotentan as per the arms they are randomized.

Dapagliflozindrug

Participants will receive 10 mg dapagliflozin as per the arms they are randomized.

Placebodrug

Participants will receive placebo as per the arms they are randomized to.