Status:
COMPLETED
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Renal Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Key
- 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)
- Key
Exclusion
- Significant infection
- acute rejection within 3 months
- prior graft loss due to rejection
- pregnancy
- positive crossmatch
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT00402168
Start Date
January 1 2007
End Date
June 1 2013
Last Update
January 5 2017
Active Locations (44)
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1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
2
National Institute Of Transplantation
Los Angeles, California, United States, 90057
3
California Institute Of Renal Research
San Diego, California, United States, 92123
4
Ucsf
San Francisco, California, United States, 94143-0106