Phase 2
Completed N=12
Belatacept Pharmacokinetic Trial in Renal Transplantation
Renal Transplantation
Source: ClinicalTrials.gov NCT00578448 ↗
Enrolled (actual)
12
Serious AEs
50.0%
Results posted
Dec 2013
Primary outcomePrimary: Mean Belatacept Serum Concentrations Between Weeks 12 and 16 by Nominal Collection Time, Following 10mg/kg IV Belatacept - Pharmacokinetic Population — 8491.00; 242667; 212800; 55970.0 ng/mL
Summary
The purpose of this study is to assess the pharmacokinetics and safety of belatacept in de novo renal transplant subjects treated with belatacept-based immunosuppressant medication
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Belatacept Serum Concentrations Between Weeks 12 and 16 by Nominal Collection Time, Following 10mg/kg IV Belatacept - Pharmacokinetic Population |
8491.00; 242667; 212800; 55970.0; 36890.0; 19063.0 | — |
| PRIMARY Maximum Observed Serum Concentration (Cmax) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept and Trough Serum Concentration Prior to Dosing (Cmin) - Pharmacokinetic Population |
7.29; 238.33 | — |
| PRIMARY Time of Maximum Observed Serum Concentration (Tmax) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population |
0.60 | — |
| PRIMARY Area Under the Concentration Time Curve Within a Dosing Interval (AUC) (TAU) Between Weeks 12 and 16 Following 10 mg/kg IV Belatacept - Pharmacokinetic Population |
21241 | — |
| PRIMARY Total Body Clearance (CLT) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population |
0.47 | — |
| PRIMARY Steady-state Volume Distribution (Vss) Following 10mg/kg IV Belatacept Between Weeks 12 and 16 - Pharmacokinetic Population |
0.11 | — |
| PRIMARY Serum Half Life (T-HALF) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population |
235.43 | — |
| SECONDARY Summary of Trough Serum Concentration of Belatacept Prior to Dosing up to 3 Years Post Transplantation - Pharmacokinetic Population |
33.499; 24.558; 21.375; 8.574; 7.289; 6.391 | — |
| SECONDARY Acute Rejection, Graft Loss, and Death up to 3 Years Post Transplantation in Planned Study and 1 Year Long Term Extension - All Treated Participants |
4; 1; 1 | — |
| SECONDARY Mean Change From Baseline to Days 5, 28, 112, 168, and 364 in Tryptophan - All Treated Participants |
-27.375; -22.765; -27.331; -18.627; -24.610 | — |
| SECONDARY Mean Change From Baseline to Days 5, 28, 112, 168, and 364 in Kynurenine - All Treated Participants |
-7.276; -8.486; -7.936; -7.589; -7.279 | — |
Eligibility Criteria
Inclusion Criteria
- Recipient of a living or deceased donor kidney
- First or second transplant
- Men and women, including women of childbearing potential, 18 years and older
Exclusion Criteria
- Panel reactive antibodies ≥ 30%
- Significant infection
Data sourced from ClinicalTrials.gov (NCT00578448). 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.