NCT06087835

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)

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,835 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase III, randomised, multicentre, double-blinded study to evaluate efficacy, safety and tolerability of treatment with zibotentan/dapagliflozin and dapagliflozin alone in participants with chronic kidney disease (CKD) and high proteinuria

Conditions

• Chronic Kidney Disease With High Proteinuria

Interventions

Type	Name	Description
DRUG	Zibotentan/Dapagliflozin	Participants will receive zibotentan/dapagliflozin in fixed-dose combination as per the arms they are randomized to
DRUG	Dapagliflozin	Participants will receive dapagliflozin as per the arms they are randomized to

Timeline

• Start date: 2023-11-07
• Primary completion: 2027-02-18
• Completion: 2027-02-18
• First posted: 2023-10-18
• Last updated: 2026-03-25

Locations

296 sites across 30 countries: United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, Denmark, France, Germany, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study