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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Kidney Disease (DKD)

In brief

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.

Key facts

Study ID

NCT04419467

Run by

CSL Behring

People needed

114

Starts

2020-09-14

Expected to finish

2022-10-24

Last updated by the study team

2023-12-06

Who can join

Age: 25 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• California Kidney Specialists (CKS) - Citrus Office — Covina, California, United States
• Valley Research - Fresno — Fresno, California, United States
• Torrance Clinical Research (TCR) - Lomita — Lomita, California, United States
• Renal Medical Associate/NARI — Lynwood, California, United States
• Amicis Research Center — Northridge, California, United States
• California Medical Research Associates, Inc — Northridge, California, United States
• Riverside Nephrology Group — Riverside, California, United States
• West Orange Endocrinology — Ocoee, Florida, United States
• East-West Medical Research Institute — Honolulu, Hawaii, United States
• Omega Clinical Research — Metairie, Louisiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Renal and Transplant Associates — Springfield, Massachusetts, United States
• University of Missouri Health System — Columbia, Missouri, United States
• Palm Medical Group, LLC - Las Vegas — Las Vegas, Nevada, United States
• Center for Thyroid & Parathyroid Disorders — Staten Island, New York, United States
• Physicians East, P.A. - Endocrinology — Greenville, North Carolina, United States
• Vanderbilt University School of Medicine — Nashville, Tennessee, United States
• Juno Research, L.L.C. — Houston, Texas, United States
• The Endocrine Center — Houston, Texas, United States
• Renal Associates, P.A. - San Antonio — San Antonio, Texas, United States
• Primary Care Providers of Texas — San Antonio, Texas, United States
• Diabetes and Metabolism Specialists (DMS) - San Antonio — San Antonio, Texas, United States
• Hunter Diabetes Centre - The AIM Centre — Merewether, New South Wales, Australia
• St Vincent's Hospital — Fitzroy, Victoria, Australia
• The Austin Hospital — Heidelberg, Victoria, Australia

Full record on ClinicalTrials.gov

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