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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-09

Study Completion Date

2016-12-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Kidney Transplant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Belatacept

Group Type EXPERIMENTAL

Belatacept

Intervention Type DRUG

Single intravenous infusion of belatacept, 7.5 mg/kg

Interventions

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Belatacept

Single intravenous infusion of belatacept, 7.5 mg/kg

Intervention Type DRUG

Other Intervention Names

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BMS-224818

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No