Status:
COMPLETED
Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease
Lead Sponsor:
CSL Behring
Conditions:
Diabetic Kidney Disease (DKD)
Eligibility:
All Genders
25+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2022
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT04419467
Start Date
September 14 2020
End Date
October 24 2022
Last Update
December 6 2023
Active Locations (37)
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1
California Kidney Specialists (CKS) - Citrus Office
Covina, California, United States, 91702
2
Valley Research - Fresno
Fresno, California, United States, 93720
3
Torrance Clinical Research (TCR) - Lomita
Lomita, California, United States, 90717
4
Renal Medical Associate/NARI
Lynwood, California, United States, 90260