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

• Status: Completed
• Trial end date: 2016-12-06
• Target enrollment: 0
• Participant gender: All

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 handles the drug.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Abatacept

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