Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants with Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria)

Study identifier:D4325C00010

ClinicalTrials.gov identifier:NCT06087835

EudraCT identifier:N/A

CTIS identifier:2023-504124-26

Recruiting

Official Title

A Phase III, Randomised, Multicentre, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin Alone in Participants with Chronic Kidney Disease and High Proteinuria

Medical condition

Chronic Kidney Disease with High Proteinuria

Phase

Phase 3

Healthy volunteers

No

Study drug

Zibotentan/Dapagliflozin, Dapagliflozin

Sex

All

Estimated Enrollment

1500

Study type

Interventional

Age

18 Years - 95 Years

Date

Study Start Date: 07 Nov 2023
Estimated Primary Completion Date: 30 Jun 2027
Estimated Study Completion Date: 30 Jun 2027

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria