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

Not Recruiting

Trial ID: NCT01791491


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.

Official Title

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

Stanford Investigator(s)


For more information regarding BMS clinical trial participation, please visit

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

   - 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

   - 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

   - Subjects with any active infection [including, but not limited to, positive
   cytomegalovirus (CMV) or BK viral (BKV) loads, BKV associated nephropathy (BKVAN), CMV
   retinitis, CMV colitis, etc.]

   - Urine albumin:creatinine ratio > 56.5 mg/mmol (> 0.5 mg albumin / mg creatinine) on a
   random voided urine specimen


drug: Belatacept

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Paul Grimm, Site 0006