Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease
Purpose
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.
Condition
- Diabetic Kidney Disease (DKD)
Eligibility
- Eligible Ages
- Over 25 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental CSL346 (low dose) |
Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions |
|
|
Experimental CSL346 (high dose) |
Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions |
|
|
Placebo Comparator Placebo |
Administered as a single IV loading dose followed by SC infusions |
|
More Details
- Status
- Completed
- Sponsor
- CSL Behring