NCT IdNCT04170543
TitleA Phase 2a Diabetic Kidney Disease Study
ConditionDiabetic Kidney Disease
OrganizationAstraZeneca
Sponsor/CollaboratorsAstraZeneca
StatusRecruiting
Location Multiple
DescriptionThis is a Phase 2a, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, PK, and immunogenicity of MEDI3506 in adult subjects with DKD defined as subjects with type 2 diabetes mellitus (T2DM) and an estimated glomerular filtration rate (eGFR) value of 30-75 mL/min/1.73 m2 who meet all eligibility criteria. Approximately 168 subjects, from 2-3 countries will be randomized to MEDI3506 dose 1 or dose 2, or placebo during a treatment period of 24 weeks. The primary objective is change in UACR from baseline at 24 weeks. Secondary objectives include evaluating safety, PK and the incidence of ADA during the treatment period.