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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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 of this treatment will also be studied

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Abatacept; Cyclosporine; Cyclosporins; Tacrolimus

Criteria

Key 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)

Key Exclusion Criteria:

• Significant infection

• acute rejection within 3 months

• prior graft loss due to rejection

• pregnancy

• positive crossmatch