Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase 2a, double-blind, randomized, placebo-controlled study will assess the efficacy, safety, tolerability, and pharmacokinetics (PK), of repeat doses of CSL346 in subjects with diabetic kidney disease (DKD) and albuminuria receiving standard of care treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSL Behring

Criteria

Inclusion Criteria:

• Male and female subjects ≥ 25 years of age with a diagnosis of type 2 diabetes mellitus (T2DM)

• Urinary ACR ≥ 150 mg/g

• eGFR ≥ 60 mL/min/1.73m2

• Glycosylated HbA1c < 12%

Exclusion Criteria:

• Current diagnosis of type 1 diabetes mellitus

• History of acute kidney injury or chronic dialysis/renal transplant

• Uncontrolled hypertension or class III / IV heart failure

• Left ventricular ejection fraction < 50% by echocardiogram

• Troponin-I > the upper reference limit

• b-type natriuretic peptide > 200 pg/mL

• ALT > 2x the upper limit of normal