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

CSL Behring

Status and phase: Completed; Phase 2

Conditions: Diabetic Kidney Disease (DKD)

Treatments: Drug: Placebo; Biological: CSL346

Study type: Interventional

Funder types: Industry

Identifiers

NCT04419467

CSL346_2001

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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 > 20 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

114 participants in 3 patient groups, including a placebo group

CSL346 (low dose)

Experimental group

Description:

Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions

Treatment:

Biological: CSL346

CSL346 (high dose)

Experimental group

Description:

Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions

Treatment:

Biological: CSL346

Placebo

Placebo Comparator group

Description:

Administered as a single IV loading dose followed by SC infusions

Treatment:

Drug: Placebo