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

Completed · Phase 2

Conditions studied: Kidney Transplant

In brief

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.

Key facts

Study ID

NCT01791491

Run by

Bristol-Myers Squibb

People needed

16

Starts

2013-05-09

Expected to finish

2016-12-06

Last updated by the study team

2017-07-24

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University Of Alabama At Birmingham — Birmingham, Alabama, United States
• Childrens Hospital Of La — Los Angeles, California, United States
• University Of California Los Angeles — Los Angeles, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Childrens National Medical Center — Washington D.C., District of Columbia, United States
• Emory University — Atlanta, Georgia, United States
• Boston Childrens Hospital — Boston, Massachusetts, United States
• Washington University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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