Zibotentan and Dapagliflozin for the Treatment of CKD (ZENITH-CKD Trial)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Kidney Disease
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 130 years
- Gender
- Both males and females
Description
The study will be conducted in approximately 200 sites in North America, South America, Africa, Asia/Pacific, and European countries. The study will be conducted in 2 parts, Part A and Part B. In both study parts, participants will be randomized to 12 weeks of treatment plus 2 weeks follow-up. After...
The study will be conducted in approximately 200 sites in North America, South America, Africa, Asia/Pacific, and European countries. The study will be conducted in 2 parts, Part A and Part B. In both study parts, participants will be randomized to 12 weeks of treatment plus 2 weeks follow-up. After screening, eligible participants will be stratified by diabetes (diabetic kidney disease [DKD] versus non-diabetes mellitus [non-DM] CKD) and baseline eGFR (below versus above 45 mL/min/1.73m^2). Participants will be randomized to treatments with 4 arms in Part A and 6 arms in Part B, in addition to receiving background local standard of care (SoC) therapy as follows: Part A: Zibotentan Dose A + Dapagliflozin 10 mg once daily. Zibotentan Dose A once daily. Dapagliflozin 10 mg once daily. Placebo once daily. Part B: Zibotentan Dose A + Dapagliflozin 10 mg once daily. Zibotentan Dose A once daily. Dapagliflozin 10 mg once daily. Placebo once daily. Zibotentan Dose B + Dapagliflozin 10 mg once daily. Zibotentan Dose C+ Dapagliflozin 10 mg once daily. Participants randomized in Part A cannot be randomized in Part B.
Tracking Information
- NCT #
- NCT04724837
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: David C Wheeler, MB ChB, MD, FRCP Centre for Nephrology Royal Free Campus University College London Rowland Hill Street London NW3 2PF United Kingdom Principal Investigator: Jamie P. Dwyer, M.D. Nephrology Clinical Trials Center Nephrology and Hypertension Vanderbilt University Medical Center Nashville TN United States of America
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