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)



Status:Recruiting
Conditions:Arthritis, Rheumatoid Arthritis, Nephrology
Therapuetic Areas:Nephrology / Urology, Rheumatology
Healthy:No
Age Range:6 - Any
Updated:11/14/2018
Start Date:March 1, 2016
End Date:June 29, 2020
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Email:Clinical.Trials@bms.com
Phone:please email:

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A Phase II Randomized, Placebo-Controlled, Double-Blind, Parallel Arms, Pilot Study to Evaluate the Efficacy and Safety of Intravenous Abatacept in Treatment Resistant Nephrotic Syndrome (Focal Segmental Glomerulosclerosis/ Minimal Change Disease)

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.


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
We found this trial at
28
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Charlotte, North Carolina 28204
Phone: 704-347-4052
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Phone: 404-712-9923
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: 205-638-9781
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
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9500 Euclid Avenue
Cleveland, Ohio 44106
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Durham, North Carolina 27710
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2401 Gillham Rd
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(816) 234-3000
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Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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1601 Northwest 12th Avenue
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(305) 243-6545
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4401 Penn Avenue
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500 S State St
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13001 E. 17th Pl
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31 Center Drive
Bethesda, Maryland 20892
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1720 2nd Avenue South
Birmingham, Alabama 35294
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300 Longwood Ave
Boston, Massachusetts 02115
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Cleveland, Ohio 44109
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
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Dallas, Texas 75235
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1801 Inwood Rd
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2160 South 1st Avenue
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550 1st Ave
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13535 Nemours Parkway
Orlando, Florida 32827
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Palo Alto, California 94304
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3451 Walnut St
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Rochester, Minnesota 55905
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Washington, District of Columbia 20010
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