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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 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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0 [day 1]) until week 1 (day 8), week 12 (day 84), and week 14 (day 98) for reporting.

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 more

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

Placebo

1995

Completed Phase 3

~2670

Dapagliflozin

2014

Completed Phase 4

~64440

Zibotentan

2019

Completed Phase 2

~810

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Who is running the clinical trial?

AstraZenecaLead Sponsor

4,397 Previous Clinical Trials

289,121,115 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