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

Phase 2

Completed

• Conditions: Diabetic Kidney Disease

• Registration Number: JPRN-jRCT2080225044
• Lead Sponsor: AstraZeneca KK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Adult men or women 18 years of age or more.

2. Diabetic kidney disease DKD defined as:

a. diagnosis of T2DM

b. eGFR 25-75 mL/min/1.73 m2

c. UACR 100-3000 mg albumin/g creatinine

3. BP 150/100 mmHg or less

4. Stable dose of ACEi or ARB Key Exclusion Criteria

Exclusion Criteria

1. Serum potassium > 5.5 mmol/L

2. Significant hepatic disease

3. Hemoglobin A1c > 10.5 %

4. B-type natriuretic peptide level > 200 pg/mL

5. History of clinically significant heart disease

6. Anticipated dialysis or renal transplantation within 1 year

7. History of underlying condition that predisposes the subject to infections

8. Significant infection (viral, bacterial, or fungal)

9. Amputation due to peripheral artery disease

10. Subjects with a positive diagnostic nucleic acid test for SARS-CoV-2

11. Pregnancy, breastfeeding or intention to become pregnant during the course of the study,

12. Any other medical condition or clinically relevant abnormal findings in physical examination, laboratory results, or electrocardiogram (ECG) during screening that, in the opinion of the investigator, may compromise the safety of the subject in the study, reduce the subject's ability to participate in the study, or interfere with evaluation of the investigational product

Study & Design

• Study Type: Interventional
• Study Design: Not specified