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)
Completed · Phase 2 · Has a placebo group
Conditions studied: Nephrotic Syndrome, Focal Segmental Glomerulosclerosis, Minimal Change Disease
In brief
The purpose of this study is evaluate if abatacept is effective and safe in decreasing the level of protein loss in the urine in patients with excessive loss of protein in the urine (nephrotic syndrome) due to either focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD). Candidates must have a prior kidney biopsy with either diagnosis. Another kidney biopsy will not be required as part of the study. Candidates must have failed or be intolerant of prior therapy for their kidney disease. The failed or intolerant therapy must include corticosteroids and at least one other drug. Candidates can be adults and children over the age of 6. Abatacept will be administered by venous infusion every 4 weeks.
Key facts
- Study ID
- NCT02592798
- Run by
- Bristol-Myers Squibb
- People needed
- 36
- Starts
- 2016-03-09
- Expected to finish
- 2020-01-28
- Last updated by the study team
- 2021-03-05
Who can join
Age: 6 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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