Status:
COMPLETED
Pharmacokinetics, Safety and Tolerability of Single-dose Belatacept in Adolescent Kidney Transplant Recipients
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Kidney Transplant
Eligibility:
All Genders
12-17 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
Key Trial Info
Start Date :
May 9 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01791491
Start Date
May 9 2013
End Date
December 6 2016
Last Update
July 24 2017
Active Locations (8)
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1
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35233
2
Childrens Hospital Of La
Los Angeles, California, United States, 90027
3
University Of California Los Angeles
Los Angeles, California, United States, 90095
4
Stanford University Medical Center
Stanford, California, United States, 94305