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

Trial ID or NCT#

NCT01791491

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: 12 Years to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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
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Investigator(s)

Paul C. Grimm

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Contact

Paul Grimm, Site 0006
650-725-5295

View on ClinicalTrials.gov