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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Durham, North Carolina 27710
(919) 684-8111
Phone: 919-684-4246
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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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
Phone: 617-525-5939
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 
Phone: 513-803-3295
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 216-444-7954
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Phone: 816-760-5594
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
Miami, Florida 33136
(305) 243-6545
Phone: 305-585-6726
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Phone: 412-692-7060
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Phone: 734-232-4852
University of Michigan The University of Michigan was founded in 1817 as one of the...
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Phone: 303-724-0183
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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31 Center Drive
Bethesda, Maryland 20892
Phone: 301-451-9946
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1720 2nd Avenue South
Birmingham, Alabama 35294
Phone: 205-934-7649
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Phone: 617-355-6129
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Charlotte, North Carolina 28204
Phone: 704-347-4052
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Cleveland, Ohio 44109
Phone: 216-778-7141
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Phone: 614-293-6205
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Dallas, Texas 75235
Phone: 214-358-2300
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Phone: 214-648-3438
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Phone: 708-216-0291
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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New York, New York 10032
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550 1st Ave
New York, New York 10016
(212) 263-7300
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New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
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13535 Nemours Parkway
Orlando, Florida 32827
(407) 567-4000
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Nemours Children's Hospital Nemours Children's Hospital in Orlando brings pediatric specialty care never before offered...
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Palo Alto, California 94304
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Rochester, Minnesota 55905
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Torrance, California 90502
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Washington, District of Columbia 20010
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