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

Phase 2

• Conditions: E11.22 Diabetes mellitus tipo 2 con nefropatia diabetica cronica; E11.22

• Registration Number: PER-001-21
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-25
• Study Completion: 2023-02-28
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: In enrollment
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1 Adult men or women = 18 years of age at Visit 1.
2 Written informed consent and any locally required authorization (eg, data privacy) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
3 DKD defined as
(a) diagnosis of T2DM and
(b) eGFR 25-75 mL/min/1.73 m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation a and
(c) UACR defined as 100-3000 mg albumin/g creatinine based on the mean of 3 sequential first morning void midstream urine samples at Visit 2.
4 BP = 150/100 mmHg at Visit 1 and Visit 3.
5 Stable dose of ACEi or ARB for at least 6 weeks prior to Visit 1 with ACEi and ARB dosing according to local guidelines. Subjects who have been deemed unable to tolerate ACEi or ARB therapy due to allergy or complications may be enrolled. Minor dose adjustment within 2 weeks of Visit 1 is acceptable (see Section 4.7.2).

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

Primary Outcome Measures

Name	Time	Method
rine albumin:creatinine ratio (UACR)<br> NAME OF THE RESULT: Urine albumin:creatinine ratio (UACR), Change from baseline to Day 169 compared to placebo<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: From Baseline to Day 169 (24 weeks)