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Diabetic Kidney Disease (DKD)

Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease
NCT04419467 | Phase 2 | Interventional

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.

Trial Information
19 Sites
100 Participants
Recruiting
25 Years

If interested, contact clinicaltrials@cslbehring.com for more information

California Kidney Specialists (CKS) Citrus Office
Covina, California, 91702, United States
Valley Research Fresno
Fresno, California, 93720, United States
Torrance Clinical Research (TCR) Lomita
Lomita, California, 90717, United States
Renal Medical AssociateNARI
Lynwood, California, 90260, United States
Amicis Research Center
Northridge, California, 91324, United States
California Medical Research Associates, Inc
Northridge, California, 91324, United States
Riverside Nephrology Group
Riverside, California, 92503, United States
EastWest Medical Research Institute
Honolulu, Hawaii, 96814, United States
Omega Clinical Research
Metairie, Louisiana, 70006, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Renal and Transplant Associates
Springfield, Massachusetts, 01107, United States
University of Missouri Health System
Columbia, Missouri, 65212, United States
Palm Medical Group, LLC Las Vegas
Las Vegas, Nevada, 89148, United States
Physicians East, P.A. Endocrinology
Greenville, North Carolina, 27834, United States
Vanderbilt University School of Medicine
Nashville, Tennessee, 37232, United States
Juno Research, L.L.C.
Houston, Texas, 77040, United States
The Endocrine Center
Houston, Texas, 77079, United States
Renal Associates, P.A. San Antonio
San Antonio, Texas, 78215, United States
Diabetes and Metabolism Specialists (DMS) San Antonio
San Antonio, Texas, 78231, United States

Study Eligibility 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%
  • 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

Additional Studies

Additional studies can be found at ClinicalTrials.gov