A Phase 2b Diabetic Kidney Disease Study

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Diabetic Kidney Disease

Treatments: Drug: Placebo; Drug: Dapagliflozin; Drug: MEDI3506

Study type: Interventional

Funder types: Industry

Identifiers

NCT04170543

D9183C00001

Details and patient eligibility

About

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

Full 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.

Enrollment: 609 patients

Sex: All

Ages: 18 to 101 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria

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

2. Diabetic kidney disease DKD defined as:

   1. diagnosis of T2DM
   2. eGFR 25-75 mL/min/1.73 m2
   3. UACR 100-3000 mg albumin/g creatinine

3. BP ≤ 150/100 mmHg

4. Stable dose of ACEi or ARB Key Exclusion Criteria

5. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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609 participants in 5 patient groups, including a placebo group

Group 1

Experimental group

Description:

MEDI3506 Dose 1 plus Dapagliflozin (Day 85 to Day 168).

Treatment:

Drug: MEDI3506

Drug: Dapagliflozin

Group 2

Experimental group

Description:

MEDI3506 Dose 2 plus Dapagliflozin (Day 85 to Day 168).

Treatment:

Drug: MEDI3506

Drug: Dapagliflozin

Group 3

Experimental group

Description:

MEDI3506 Dose 3 plus Dapagliflozin (Day 85 to Day 168).

Treatment:

Drug: MEDI3506

Drug: Dapagliflozin

Group 4

Experimental group

Description:

MEDI3506 Dose 4 plus Dapagliflozin (Day 85 to Day 168).

Treatment:

Drug: MEDI3506

Drug: Dapagliflozin

Group 5

Placebo Comparator group

Description:

Placebo (volume matched) plus Dapagliflozin (Day 85 to Day 168).

Treatment:

Drug: Dapagliflozin

Drug: Placebo