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SGLT2 Inhibitor
Zibotentan and Dapagliflozin for the Treatment of CKD (ZENITH-CKD Trial) (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 baseline (week 0 [day 1]) until week 1 (day 8), week 12 (day 84), and week 14 (day 98)
Summary
This trial tests zibotentan and dapagliflozin, alone or together, in people with chronic kidney disease. The goal is to see if these drugs can improve kidney function by improving blood flow and reducing sugar levels in the blood. Dapagliflozin has been shown to reduce the risk of kidney failure in patients with chronic kidney disease, both with and without type 2 diabetes.
Eligible Conditions
- Chronic Kidney Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline (week 0 [day 1]) until week 1 (day 8), week 12 (day 84), and week 14 (day 98)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0 [day 1]) until week 1 (day 8), week 12 (day 84), and week 14 (day 98)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12
Secondary study objectives
Change in Office Diastolic Blood Pressure From Baseline to Week 12
Change in Office Systolic Blood Pressure From Baseline to Week 12
Change in UACR From Baseline to Week 12
+3 moreTrial 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
Placebo
1995
Completed Phase 3
~2670
Dapagliflozin
2014
Completed Phase 4
~64440
Zibotentan
2019
Completed Phase 2
~810
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,164,057 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