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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Conditions

Kidney Transplant

Treatments

Drug: Belatacept

Study type

Interventional

Funder types

Industry

Identifiers

NCT01791491

2011-005257-31 (EudraCT Number)

IM103-144

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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