A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Renal Outcomes and Mortality in Participants With Chronic Kidney Disease (Elevate-CKD)

AstraZeneca

Summary

This is a Phase III, randomized, double-blind, parallel-group, placebo-controlled multicenter study to investigate outcomes with elecoglipron compared with placebo in participants with CKD with and without T2DM who are on background SGLT2i (dapagliflozin) as GDMT and other SoC treatments for CKD.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Adults with confirmed CKD; UACR ≥30 mg/g and eGFR ≥20 mL/min/1.73 m² within specified ranges. * On stable, patient maximum tolerated, labeled daily dose of ACEI or ARB for ≥4 weeks at least 28 days before screening. Exclusion Criteria: * BMI \<23 kg/m² at screening * History of type 1 diabetes mellitus * HbA1c ≥10% (86 mmol/mol) at screening * Currently receiving, or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema. * Have had more than one episode of severe hypoglycemia within 180 days prior to screening, or hypoglycemia u…

A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Renal Outcomes and Mortality in Participants With Chronic Kidney Disease (Elevate-CKD)

Summary

Eligibility

Interventions

Locations (715)