Phase 2
Completed N=9
Pharmacokinetics, Safety and Tolerability of Single-dose Belatacept in Adolescent Kidney Transplant Recipients
Source: ClinicalTrials.gov NCT01791491 ↗Enrolled (actual)
9
Serious AEs
44.4%
Results posted
Jun 2017
Primary outcomePrimary: Maximum Observed Serum Concentration (Cmax) of Belatacept — 151 micrograms per milliliter
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Serum Concentration (Cmax) of Belatacept |
151 | — |
| PRIMARY Time of Maximum Observed Plasma Concentration (Tmax) of Belatacept |
0.733 | — |
| PRIMARY Half-Life of Elimination (T-Half) of Belatacept |
173 | — |
| PRIMARY 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 |
15145; 15407 | — |
| PRIMARY Total Body Clearance (CLT) of Belatacept |
0.483 | — |
| PRIMARY Volume of Distribution at Steady-state (Vss) of Belatacept |
0.088 | — |
| SECONDARY Number of Participants With Death, Serious Adverse Events (SAEs), and Treatment-related Adverse Event (AE) |
0; 4; 0 | — |
| SECONDARY Number of Participants With Positive Belatacept-induced Immunogenicity Response |
— | — |
| SECONDARY Percentage of CD86 Receptor Occupancy |
94.70; 77.99; 51.45 | — |
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
Data sourced from ClinicalTrials.gov (NCT01791491). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.