NCT04170543

A Phase 2b Diabetic Kidney Disease Study

A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects With Diabetic Kidney Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 609 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 101 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects with Diabetic Kidney Disease

Detailed description

This is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, PK, and immunogenicity of MEDI3506 on top of standard of care, including angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) and dapagliflozin in adult subjects with diabetic kidney disease, defined as subjects with type 2 diabetes mellitus (T2DM) and an estimated glomerular filtration rate (eGFR) of 25-75 mL/min/1.73 m2 with a UACR in the range of 100-3000 mg/g, who meet all eligibility criteria. Approximately 565 subjects, among multiple countries will be randomized to MEDI3506 dose 1, 2, 3 or dose 4, or placebo during a treatment period of 24 weeks. All subjects will receive Dapagliflozin daily, as administered orally from Day 85 to Day 168. The primary objective is to evaluate the effect of MEDI3506 on albuminuria in subjects with DKD. Secondary objectives include evaluating safety, PK and the incidence of ADA during the treatment period.

Conditions

• Diabetic Kidney Disease

Interventions

Type	Name	Description
DRUG	MEDI3506	Dose 1, Dose 2, Dose 3, Dose 4
DRUG	Placebo	Placebo
DRUG	Dapagliflozin	Dapagliflozin 10 mg

Timeline

• Start date: 2019-11-18
• Primary completion: 2023-05-16
• Completion: 2023-05-16
• First posted: 2019-11-20
• Last updated: 2024-07-10
• Results posted: 2024-07-10

Locations

97 sites across 7 countries: United States, Argentina, Canada, Chile, Japan, Peru, South Korea

Regulatory

• FDA-regulated drug study