Pharmacokinetics, Safety and Tolerability of Single-dose Belatacept in Adolescent Kidney Transplant Recipients



Status:Active, not recruiting
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:12 - 17
Updated:7/28/2016
Start Date:May 2013
End Date:December 2016

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A Phase 2 Multi-Center, Randomized Conversion Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belatacept Administered to Pediatric Subjects With a Stable Renal Transplant

The purpose of this study is to evaluate how well adolescent kidney transplant patients
tolerate a single dose of belatacept they receive at least 6 months after transplant
surgery, and how their body handles the drug.


For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Male and Female subjects,12-17 years old

- Receiving CNI-based maintenance immunosuppression since the time of renal
transplantation in accordance with local standard of care

- Stable renal function, in the opinion of the investigator, with a cGFR>45
mL/min/1.73m2 at the time of enrollment (per updated Schwartz Formula)

- Adolescent Recipients of a renal allograft from a living donor or a deceased donor at
least 6 months prior to enrollment

- Subject must be receiving a calcineurin inhibitor (CNI)-based [cyclosporine (CsA)
[any formulation] or Tacrolimus (TAC)] immunosuppressive regimen

- Subject must be receiving adjunctive background maintenance immunosuppression with
mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium
(EC-MPS)/mycophenolic acid (MPA)

- Subjects may be receiving maintenance corticosteroids in accordance with the local
standard of care

- Negative Interferon Gamma Release Assay (IGRA) such as QuantiFERON-TB Gold test or
T-Spot-TB

- FOCBP must have negative serum or urine pregnancy test within 24 hrs prior to start
of study medication

- Subject must have stable estimated glomerular filtration rate (GFR) ≥45 mL/min/1.73m2
(updated Schwartz formula)

Exclusion Criteria:

- Epstein-Barr virus (EBV) serostatus negative or unknown at time of transplant and
screening

- History of any treated or biopsy proven acute rejection (BPAR) within 3 months prior
to enrollment

- Subjects who have experienced more than 1 episode of acute rejection (AR) of the
current allograft or any antibody-mediated AR

- Significant proteinuria

- Active infection
We found this trial at
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District of Columbia, District of Columbia 20010
Phone: 202-476-2245
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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: 205-638-2792
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Los Angeles, California 90095
310-825-4321
Phone: 310-206-8415
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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1 Brookings Drive
St. Louis, Missouri 63110
 (314) 935-5000
Phone: 314-747-1349
Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Phone: 617-355-8314
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Los Angeles, California 90027
Phone: 323-361-7299
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Phone: 650-725-5295
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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