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Pharmacokinetics, Safety and Tolerability of Single-dose Belatacept in Adolescent Kidney Transplant Recipients
Not Recruiting
Trial ID: NCT01791491
Purpose
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)
Eligibility
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
- 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
Intervention(s):
drug: Belatacept
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Paul Grimm, Site 0006
650-725-5295