Clinical trial NCT01791491: Pharmacokinetics, Safety and Tolerability of Single-dose Belatacept in Adolescent Kidney Transplant Recipients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Transplant
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 16
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Maximum Observed Serum Concentration (Cmax) of Belatacept
timeFrame: Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57
measure: Time of Maximum Observed Plasma Concentration (Tmax) of Belatacept
timeFrame: Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57
measure: Half-Life of Elimination (T-Half) of Belatacept
timeFrame: Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57
measure: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC (0-T)) and Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Belatacept
timeFrame: Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57
measure: Total Body Clearance (CLT) of Belatacept
timeFrame: Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57
measure: Volume of Distribution at Steady-state (Vss) of Belatacept
timeFrame: Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57
Secondary outcomes:
measure: Number of Participants With Death, Serious Adverse Events (SAEs), and Treatment-related Adverse Event (AE)
timeFrame: Date of First Dose to 24 weeks post the last dose; approximately 26 weeks
measure: Number of Participants With Positive Belatacept-induced Immunogenicity Response
timeFrame: Baseline/Day 1, Days 15, 29, and 57
measure: Percentage of CD86 Receptor Occupancy
timeFrame: 0.5 hours post dose on Day 1, Day 29 and Day 57
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Of Alabama At Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: Childrens Hospital Of La
state: California
city: Los Angeles
country: United States
facility: University Of California Los Angeles
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Washington, D.C.
country: United States
facility: Childrens National Medical Center
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Boston
country: United States
facility: Boston Childrens Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: