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A Study to Evaluate the Safety and Efficacy of AZD5718 in Participants With Proteinuric Chronic Kidney Disease

NCT04492722 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 613

Last updated 2024-12-20

Study results available
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Summary

The purpose of the study is to evaluate the dose-response efficacy, safety, and pharmacokinetics (PK) of AZD5718 in participants with proteinuric chronic kidney disease.

Conditions

Interventions

DRUG

AZD5718

Participants will receive once daily oral dose of AZD5718 as per the arms they are randomised, and will continue until Week 20.

DRUG

Dapagliflozin 10 mg

Participants will receive once daily oral dose of 10 mg dapagliflozin for 8 weeks as an add-on therapy.

DRUG

Placebo

Participants will receive once daily oral dose of placebo matched to AZD5718, and will continue until Week 20.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Emerald Clinical Inc.

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Hiddo J. L. Heerspink · Department of Clinical Pharmacy and Pharmacology University Medical Centre Groningen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-09-06
Completion
2022-09-06
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Germany
  • Hungary
  • Israel
  • Japan
  • Malaysia
  • Poland
  • Taiwan
  • 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 NCT04492722 on ClinicalTrials.gov