Trial record 1 of 1 for:    NCT00402168
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A Study of BMS-224818 (Belatacept) in Patients Who Have Undergone a Kidney Transplant and Are Currently on Stable Cyclosporine or Tacrolimus Regimen With or Without Corticosteroids

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00402168
First received: November 20, 2006
Last updated: August 12, 2013
Last verified: August 2013

November 20, 2006
August 12, 2013
January 2007
June 2009   (final data collection date for primary outcome measure)
The change in calculated glomerular filtration rate (GFR) [ Time Frame: from baseline to 12 months post randomization ] [ Designated as safety issue: Yes ]
The change in calculated glomerular filtration rate (GFR) from baseline to 12 months post randomization
Complete list of historical versions of study NCT00402168 on ClinicalTrials.gov Archive Site
  • Assess the incidence/severity of acute rejection [ Time Frame: At 6 and 12 months ] [ Designated as safety issue: Yes ]
  • death and graft loss [ Time Frame: At 6 and 12 months ] [ Designated as safety issue: Yes ]
  • discontinuation or dose alteration due to declining renal function [ Time Frame: At 6 and 12 months ] [ Designated as safety issue: Yes ]
  • quality of life and overall safety and tolerability of a belatacept-based immunosuppression regimen [ Time Frame: At 6 and 12 months ] [ Designated as safety issue: Yes ]
  • At 6 and 12 months will assess the incidence/severity of acute rejection
  • death and graft loss
  • discontinuation or dose alteration due to declining renal function
  • quality of life and overall safety and tolerability of a belatacept-based immunosuppression regimen
Not Provided
Not Provided
 
A Study of BMS-224818 (Belatacept) in Patients Who Have Undergone a Kidney Transplant and Are Currently on Stable Cyclosporine or Tacrolimus Regimen With or Without Corticosteroids
Belatacept Conversion Trial in Renal Transplantation

The purpose of this study is to learn if conversion to belatacept from cyclosporine or tacrolimus will preserve kidney function in people who have had a kidney transplant. The safety and tolerability of this treatment will also be studied

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Transplant
  • Drug: Belatacept
    IV, IV Infusion, 5 mg/kg once every 28 days for one year
    Other Name: BMS-224818
  • Drug: Cyclosporine A
    Tablets, Oral, Trough of 100-250 ng/mL, 2X daily for one year
  • Drug: Tacrolimus
    Tablets, Oral, Trough of 5-10 ng/mL, 2X daily for one year
  • Experimental: A
    Intervention: Drug: Belatacept
  • Active Comparator: B
    Interventions:
    • Drug: Cyclosporine A
    • Drug: Tacrolimus
Rostaing L, Massari P, Garcia VD, Mancilla-Urrea E, Nainan G, del Carmen Rial M, Steinberg S, Vincenti F, Shi R, Di Russo G, Thomas D, Grinyó J. Switching from calcineurin inhibitor-based regimens to a belatacept-based regimen in renal transplant recipients: a randomized phase II study. Clin J Am Soc Nephrol. 2011 Feb;6(2):430-9. Epub 2010 Nov 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
171
June 2013
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women age 18 and older
  • 6-36 months after kidney transplant receiving cyclosporine or tacrolimus
  • calculated GFR ≥35 and ≤75mL/min/1.73 m²
  • subjects must have completed 1 year in the IM103-010ST and remained on study treatment (Long Term Extension)

Exclusion Criteria:

  • Significant infection
  • acute rejection within 3 months
  • prior graft loss due to rejection
  • pregnancy
  • positive crossmatch
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   France,   Germany,   India,   Mexico,   Poland,   Spain
 
NCT00402168
IM103-010, LEA29Y
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
August 2013

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