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SGLT2 Inhibitor

Dapagliflozin for Chronic Kidney Disease (ZENITH-CKD Trial)

Phase 2
Waitlist Available
Led By Jamie P. Dwyer, M.D.
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 1 (day 8) until week 12 (day 84)
Awards & highlights

ZENITH-CKD Trial Summary

This trial will study the effects of two drugs, zibotentan and dapagliflozin, either together or separately, in patients with chronic kidney disease.

Eligible Conditions
  • Chronic Kidney Disease

ZENITH-CKD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 1 (day 8) until week 12 (day 84)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 1 (day 8) until week 12 (day 84) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Log-transformed Urinary Albumin to Creatinine Ratio (UACR) from baseline to Week 12
Secondary outcome measures
Change in Blood Pressure from baseline to Week 12
Change in Log-transformed UACR from baseline to Week 12
Change in eGFR from Baseline to Week 1, Week 12 and Week 14
+3 more

ZENITH-CKD Trial Design

3Treatment groups
Experimental Treatment
Group I: Zibotentan Dose B + DapagliflozinExperimental Treatment2 Interventions
Participants will receive once daily oral dose B of zibotentan and 10 mg dapagliflozin for 12 weeks.
Group II: Zibotentan Dose A + DapagliflozinExperimental Treatment2 Interventions
Participants will receive once daily oral dose A of zibotentan and 10 mg dapagliflozin for 12 weeks.
Group III: Placebo + DapagliflozinExperimental Treatment2 Interventions
Participants will receive once daily oral dose of dapagliflozin 10 mg and placebo for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin
2014
Completed Phase 4
~64440
Placebo
1995
Completed Phase 3
~2670
Zibotentan
2019
Completed Phase 2
~810

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,286 Previous Clinical Trials
288,619,508 Total Patients Enrolled
Jamie P. Dwyer, M.D.Principal InvestigatorNephrology Clinical Trials Center Nephrology and Hypertension Vanderbilt University Medical Center Nashville TN United States of America
David C Wheeler, MB ChB, MD, FRCPPrincipal InvestigatorCentre for Nephrology Royal Free Campus University College London Rowland Hill Street London NW3 2PF United Kingdom
~133 spots leftby May 2025
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