The purpose of this study is to learn if Belatacept can provide protection from organ rejection following kindney transplantation while avoiding some of the toxic effects of standard immunosupressive medications such as kidney damage. Effects on kidney function and patient survival as well as drug safety will also be studied.

Condition	Intervention	Phase
Kidney Transplantation Chronic Kidney Failure	Drug: Belatacept	Phase III

Further study details as provided by Bristol-Myers Squibb:

Primary Outcomes: The composite of subject and graft survival by 12 months.; The composite of measured GFR <60ml/min/1.73 m2 at Month 12 or a decrease in measured GFR >= 10mL/min/1.73m2 from Month 3 to Month 12.; The incidence of acute rejection by 12 months
Secondary Outcomes: Measured GFR at 12 months.; Biopsy-proven chronic allografnephropathy at 12 months.
Expected Total Enrollment:  660

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• The subject is a recipient of a living donor or deceased donor kidney transplant.

  • Male or Female, 18 or older

Exclusion Criteria:

• First time recipient, PRA >- 50% or for retransplantation PRA >- 30%.
• If retransplantation, previous graft loss cannot be due to acute rejection.
• Positve cross match.
• Subject receiveing extended criteria donor (ECD) organ

Please refer to this study by ClinicalTrials.gov identifier  NCT00256750

BMS Call Center      1-866-892-1BMS  Ext. 323 
BMS Call Center Outside the US and Canada      1-941-906-4711  Ext. 323 

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Study ID Numbers:  IM103-008
Last Updated:  December 21, 2005
Record first received:  November 15, 2005
ClinicalTrials.gov Identifier:  NCT00256750
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10