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)
NCT ID: NCT02592798
Last Updated: 2021-03-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
2016-03-09
2020-01-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Abatacept
* 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
Abatacept
Abatacept IV administered on Day 1, 15, 29 and then every 28 days
Placebo
* 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
Normal Saline
Normal Saline administer on Day 1, 15, 29 and then every 28 days
D5W
Dextrose 5% in Water (D5W) administered on Day 1, 15, 29 and then every 28 days
Interventions
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Abatacept
Abatacept IV administered on Day 1, 15, 29 and then every 28 days
Normal Saline
Normal Saline administer on Day 1, 15, 29 and then every 28 days
D5W
Dextrose 5% in Water (D5W) administered on Day 1, 15, 29 and then every 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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The University Of Alabama At Birmingham
Birmingham, Alabama, United States
University of Alabama-Birmingham-Parent Account
Birmingham, Alabama, United States
Los Angeles Biomedical Research Institute
Torrance, California, United States
University Of Colorado Denver
Aurora, Colorado, United States
Children's National Health System
Washington D.C., District of Columbia, United States
University Of Miami Miller School Of Medicine
Miami, Florida, United States
Nemours Childrens Hospital
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
Loyola University Medical Center
Maywood, Illinois, United States
NIH Clinical Center - NIDDK
Bethesda, Maryland, United States
Boston Childrens Hospital
Boston, Massachusetts, United States
Brigham And Women'S Hosp Inc.
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Childrens Mercy Hospital
Kansas City, Missouri, United States
New York University Langone Medical Center
New York, New York, United States
Columbia University Medical Center (Cumc)
New York, New York, United States
Levine Children's Hospital
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, United States
The Metro Health System
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, United States
Local Institution
Pittsburgh, Pennsylvania, United States
Renal Disease Research Institute
Dallas, Texas, United States
University Of Texas Southwestern Medical Center
Dallas, Texas, United States
Countries
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References
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Liu ID, Willis NS, Craig JC, Hodson EM. Interventions for idiopathic steroid-resistant nephrotic syndrome in children. Cochrane Database Syst Rev. 2025 May 8;5(5):CD003594. doi: 10.1002/14651858.CD003594.pub7.
Azukaitis K, Palmer SC, Strippoli GF, Hodson EM. Interventions for minimal change disease in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2022 Mar 1;3(3):CD001537. doi: 10.1002/14651858.CD001537.pub5.
Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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2015-005450-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM101-566
Identifier Type: -
Identifier Source: org_study_id
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