NCT04492722

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

A Phase 2b Randomised, Double-Blind, Placebo-Controlled, Multi-Centre, Dose-Ranging Study of AZD5718 in Participants With Proteinuric Chronic Kidney Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 613 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will be conducted in approximately 118 study centers across 12 countries. The overall study period will be around 28 weeks. Approximately 632 participants comprising of 67% diabetic kidney disease (DKD) and 33% non-DKD participants will be enrolled. After a screening period of up to 4 weeks, the participants will be randomised in a 1:1:1:1 ratio to receive one of the doses of AZD5718 and/or placebo for the first 12 weeks (Day 85 \[treatment period 1\]), with an add-on therapy of 8 weeks of dapagliflozin for all participants from Week 12 to 20 (Day 85 to 141 \[treatment period 2\]). Only participants still taking their assigned treatment from treatment period 1 will progress to treatment period 2. Any participant with urine albumin to creatinine ratio (ACR) \< 30 mg/g at Week 12 will be excluded from treatment period 2. The eligibility check to enter treatment period 2 will be done at Visit 7 (Week 12) using the last available urine ACR result. The final analysis will be done after all participants have completed follow-up period of up to 4 weeks. The expected total study duration, including the Screening Period, for each participant will be at least 28 weeks.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-09-06
• Completion: 2022-09-06
• First posted: 2020-07-30
• Last updated: 2024-12-20
• Results posted: 2023-12-26

Locations

111 sites across 11 countries: United States, Argentina, Brazil, Germany, Hungary, Israel, Japan, Malaysia, Poland, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study