Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease
- Conditions
- Diabetic Kidney Disease (DKD)
- Interventions
- Biological: CSL346Drug: Placebo
- Registration Number
- NCT04419467
- Lead Sponsor
- CSL Behring
- 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 disease (DKD) and albuminuria receiving standard of care treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
- 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%
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CSL346 (high dose) CSL346 Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions Placebo Placebo Administered as a single IV loading dose followed by SC infusions CSL346 (low dose) CSL346 Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Urinary Albumin-to-creatinine Ratio (ACR) Baseline up to Week 16 Data are presented as the geometric mean (GM) of percent change, which is calculated as the geometric mean of the Week 16 ACR to baseline, expressed as percent change from baseline.
- Secondary Outcome Measures
Name Time Method Percentage of Subjects With TEAEs Up to 24 weeks Number of Subjects With Adverse Events of Special Interest (AESIs) Up to 24 weeks Data are presented for treatment-emergent AESIs.
Observed Value and Mean Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Baseline up to 24 weeks Observed Value and Mean Change From Baseline in Systolic Blood Pressure Baseline up to 24 weeks Percentage of Subjects With AESIs Up to 24 weeks Data are presented for treatment-emergent AESIs.
Observed Value and Mean Change From Baseline in Serum Creatinine Baseline up to 24 weeks Observed Value and Mean Change From Baseline in Diastolic Blood Pressure Baseline up to 24 weeks Time to Reach Cmax in Serum (Tmax) After IV Loading Dose of CSL346 in Serum Samples Up to 120 minutes after the IV loading dose for CSL346 Cmax After First Subcutaneous (SC) Dose of CSL346 in Serum Samples From Day 1 to Day 29 Maximum Concentration (Cmax) After Intravenous (IV) Loading Dose of CSL346 in Serum Samples Up to 120 minutes after the IV loading dose for CSL346 Area Under the Concentration-time Curve in First Dosing Interval From Day 1 to Day 29 Number of Subjects With Treatment-emergent Adverse Events (TEAEs) Up to 24 weeks Tmax After First SC Dose of CSL346 in Serum Samples From Day 1 to Day 29 Number of Subjects Positive for Anti-drug Antibodies Weeks 4, 8, and 16 Data are presented for participants who received treatment with CSL346. Any anti-drug antibodies detected in participants who received treatment with Placebo were considered not specific to CSL346 and of no clinical relevance.
Trough Concentration After Each Dose 29 days after each dose Percentage of Subjects Positive for Anti-drug Antibodies Weeks 4, 8, and 16 Data are presented for participants who received treatment with CSL346. Any anti-drug antibodies detected in participants who received treatment with Placebo were considered not specific to CSL346 and of no clinical relevance.
Trial Locations
- Locations (37)
Valley Research - Fresno
🇺🇸Fresno, California, United States
Riverside Nephrology Group
🇺🇸Riverside, California, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
University of Missouri Health System
🇺🇸Columbia, Missouri, United States
Juno Research, L.L.C.
🇺🇸Houston, Texas, United States
The Endocrine Center
🇺🇸Houston, Texas, United States
St Vincent's Hospital
🇦🇺Fitzroy, Victoria, Australia
Renal Medical Associate/NARI
🇺🇸Lynwood, California, United States
Amicis Research Center
🇺🇸Northridge, California, United States
Center for Thyroid & Parathyroid Disorders
🇺🇸Staten Island, New York, United States
Physicians East, P.A. - Endocrinology
🇺🇸Greenville, North Carolina, United States
Sunshine Hospital
🇦🇺St Albans, Victoria, Australia
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Lipid and Diabetes Research Group
🇳🇿Christchurch, New Zealand
Vanderbilt University School of Medicine
🇺🇸Nashville, Tennessee, 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
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
University of Puerto Rico - Puerto Rico Clinical and TRC
🇵🇷San Juan, Puerto Rico
Palm Medical Group, LLC - Las Vegas
🇺🇸Las Vegas, Nevada, United States
Fundación de Investigación
🇵🇷San Juan, Puerto Rico
Renal and Transplant Associates
🇺🇸Springfield, Massachusetts, United States
California Kidney Specialists (CKS) - Citrus Office
🇺🇸Covina, California, United States
Torrance Clinical Research (TCR) - Lomita
🇺🇸Lomita, California, United States
West Orange Endocrinology
🇺🇸Ocoee, Florida, United States
California Medical Research Associates, Inc
🇺🇸Northridge, California, United States
Omega Clinical Research
🇺🇸Metairie, Louisiana, United States
Hunter Diabetes Centre - The AIM Centre
🇦🇺Merewether, New South Wales, Australia
The Austin Hospital
🇦🇺Heidelberg, Victoria, Australia
The Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Lyell McEwin Hospital
🇦🇺Elizabeth Vale, Australia
1240130 - University Health Network
🇨🇦Toronto, Ontario, Canada
3760045 - Kaplan Medical Center
🇮🇱Reẖovot, Israel
3760044 - Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv-Yafo, Israel
Middlemore Hospital
🇳🇿Auckland, New Zealand
Endocrine Associates - Wellington
🇳🇿Wellington, New Zealand