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Belatacept Pharmacokinetic Trial in Renal Transplantation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00578448
First received: December 19, 2007
Last updated: February 28, 2012
Last verified: February 2012
History of Changes

December 19, 2007
February 28, 2012
March 2008
November 2008   (final data collection date for primary outcome measure)
  • Maximum Observed Serum Concentration (Cmax) [ Time Frame: over a 4-month period ] [ Designated as safety issue: No ]
  • Time of Maximum Observed Concentration (Tmax) [ Time Frame: over a 4-month period ] [ Designated as safety issue: No ]
  • Trough Serum Concentration prior to dosing (Cmin) [ Time Frame: over a 4-month period ] [ Designated as safety issue: No ]
  • Area under the Concentration Time Curve within a dosing interval (AUC) (TAU) [ Time Frame: over a 4-month period ] [ Designated as safety issue: No ]
  • Total body clearance (CLT) [ Time Frame: over a 4-month period ] [ Designated as safety issue: No ]
  • Steady-state volume distribution (Vss) [ Time Frame: over a 4-month period ] [ Designated as safety issue: No ]
Assessment of non-compartmental pharmacokinetics [ Time Frame: over a 4-month period ]
Complete list of historical versions of study NCT00578448 on ClinicalTrials.gov Archive Site
Acute rejection, graft loss, and death [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
Acute rejection, graft loss, and death [ Time Frame: at 1 year ]
Not Provided
Not Provided
 
Belatacept Pharmacokinetic Trial in Renal Transplantation
An Open-label Pharmacokinetic Study in De Novo Renal Transplant Subjects Receiving a Belatacept Based Immunosuppressant Regimen

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
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Transplantation
Drug: Belatacept
IV infusion
Other Name: BMS-224818
  • Active Comparator: A

    10mg/kg

    6 doses (Day 1, 5, week 2, 4, 8 and 12) for 12 weeks

    Intervention: Drug: Belatacept
  • Active Comparator: B

    5mg/kg

    33 doses (every 4 weeks) for 144 weeks

    Intervention: Drug: Belatacept
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12
August 2012
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Mexico
 
NCT00578448
IM103-047
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP