Clinical trial NCT00578448: Belatacept Pharmacokinetic Trial in Renal Transplantation
Official title: An Open-label Pharmacokinetic Study in De Novo Renal Transplant Subjects Receiving a Belatacept Based Immunosuppressant Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Transplantation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-12-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


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

Primary outcomes:
measure: Mean Belatacept Serum Concentrations Between Weeks 12 and 16 by Nominal Collection Time, Following 10mg/kg IV Belatacept - Pharmacokinetic Population
timeFrame: Day 84 to Day 112
measure: 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
timeFrame: Day 84 to Day 112
measure: Time of Maximum Observed Serum Concentration (Tmax) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population
timeFrame: Day 84 to Day 112
measure: 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
timeFrame: Day 82 to Day 112
measure: Total Body Clearance (CLT) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population
timeFrame: Day 84 to Day 112
measure: Steady-state Volume Distribution (Vss) Following 10mg/kg IV Belatacept Between Weeks 12 and 16 - Pharmacokinetic Population
timeFrame: Day 84 to Day 112
measure: Serum Half Life (T-HALF) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population
timeFrame: Day 84 to Day 112
Secondary outcomes:
measure: Summary of Trough Serum Concentration of Belatacept Prior to Dosing up to 3 Years Post Transplantation - Pharmacokinetic Population
timeFrame: Day 1 to Day 1092
measure: Acute Rejection, Graft Loss, and Death up to 3 Years Post Transplantation in Planned Study and 1 Year Long Term Extension - All Treated Participants
timeFrame: Day 1 up to 4 years post transplantation
measure: Mean Change From Baseline to Days 5, 28, 112, 168, and 364 in Tryptophan - All Treated Participants
timeFrame: Baseline to Day 364
measure: Mean Change From Baseline to Days 5, 28, 112, 168, and 364 in Kynurenine - All Treated Participants
timeFrame: Day 1 to Day 364
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Western New England Renal & Transplant
state: Massachusetts
city: Detriot
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Cuernavaca
country: Mexico
facility: Local Institution
state: Morelos
city: Aguascalientes
country: Mexico
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: