TerminatedPhase 2

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

Stopped: The Sponsor decided to terminate the study early due to lack of efficacy. There were no safety concerns related to the study.

United States613 participantsStarted 2020-10-01

Plain-language 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.

Who can participate

Age range18 Years – 130 Years

SexALL

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Exclusion criteria

✕. History of QT prolongation associated with other medications that required discontinuation of that medication, and congenital long QT syndrome.
✕. Acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass grafting within 6 months.
✕. High degree atrioventricular block II-III, sinus node dysfunction.
✕. Stroke within 3 months, heart failure, and anticipated dialysis or renal transplantation within 1 year.
✕. Any other condition or clinically relevant abnormal findings in physical examination, laboratory results or ECG during screening period.
✕. History of substance dependence or a positive screen for drugs or alcohol abuse. Alcohol and drug screening to be completed for all participants locally with laboratory kits provided by the central laboratory.

What they're measuring

Change From Baseline in Reduction of Urine Albumin to Creatinine Ratio (ACR) to Week 20

Timeframe: Week 1 (Baseline) to Week 20

Trial details

NCT IDNCT04492722

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-06

Results submitted2023-09-05

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