Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Adults and Children 6 Years and Older With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)
Nephrotic Syndrome, Focal Segmental Glomerulosclerosis, Minimal Change Disease
About this trial
This is an interventional treatment trial for Nephrotic Syndrome
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Male and female subjects ages ≥ 6 years
- Subjects resistant to corticosteroids, calcineurin inhibitors (cyclosporine and tacrolimus), sirolimus, mycophenolate mofetil (MMF), mycophenolic acid (MPA), or cyclophosphamide or intolerant to at least 2 of these
- UPCR ≥ 3 at screening
- FSGS or MCD confirmed by renal biopsy
- eGFR ≥ 45 for children and adults
- Concomitant use of angiotensin-converting-enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) at stable doses for at least 2 weeks or have intolerance documented in the source documents maintained at the site
Exclusion Criteria:
- Kidney diseases other than FSGS or MCD
- Collapsing FSGS
- Systemic lupus erythematosus
- Diabetes mellitus, both type 1 and type 2
- Clinically significant congestive heart failure
- Post renal transplantation, including relapsing post-transplant FSGS
- Body mass index (BMI): > 40 in subjects ≥ 18 years of age and ≥ 99% percentile for subjects < 18 years of age
Other protocol defined inclusion/exclusion criteria may apply
Sites / Locations
- The University Of Alabama At Birmingham
- University of Alabama-Birmingham-Parent Account
- Los Angeles Biomedical Research Institute
- University Of Colorado Denver
- Children's National Health System
- University Of Miami Miller School Of Medicine
- Nemours Childrens Hospital
- Emory University
- Loyola University Medical Center
- NIH Clinical Center - NIDDK
- Boston Childrens Hospital
- Brigham And Women'S Hosp Inc.
- University of Michigan
- Mayo Clinic
- Childrens Mercy Hospital
- New York University Langone Medical Center
- Columbia University Medical Center (Cumc)
- Levine Children's Hospital
- Duke University
- Cincinnati Children'S Hospital Medical Center
- The Metro Health System
- Cleveland Clinic
- The Ohio State University Wexner Medical Center
- University Of Pennsylvania
- Local Institution
- Renal Disease Research Institute
- University Of Texas Southwestern Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Abatacept
Placebo
Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period. Open Label Period (OLE): Abatacept IV administered every 28 days
Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period. Open Label Period (OLE): Abatacept IV administered every 28 days