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Zibotentan and Dapagliflozin for the Treatment of CKD (ZENITH-CKD Trial)

NCT04724837 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 542

Last updated 2024-07-30

Study results available
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Summary

The purpose of the study is to assess efficacy, safety and tolerability of treatment with zibotentan and dapagliflozin in combination and dapagliflozin 10 mg as monotherapy in participants with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73 m\^2, and urinary albumin to creatinine ratio (UACR) ≥ 150 mg/g and ≤ 5000 mg/g.

Conditions

Interventions

DRUG

Zibotentan

Participants will receive zibotentan as per the arms they are randomized.

DRUG

Dapagliflozin

Participants will receive 10 mg dapagliflozin as per the arms they are randomized.

DRUG

Placebo

Participants will receive placebo as per the arms they are randomized to.

Sponsors & Collaborators

Principal Investigators

  • David C Wheeler, MB ChB, MD, FRCP · Centre for Nephrology Royal Free Campus University College London Rowland Hill Street London NW3 2PF United Kingdom

  • Jamie P. Dwyer, M.D. · Nephrology Clinical Trials Center Nephrology and Hypertension Vanderbilt University Medical Center Nashville TN United States of America

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-28
Primary Completion
2023-06-01
Completion
2023-06-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Bulgaria
  • Canada
  • Croatia
  • Denmark
  • Georgia
  • Hungary
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • Poland
  • Slovakia
  • South Africa
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04724837 on ClinicalTrials.gov