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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Renal Transplant

Treatments: Drug: Belatacept; Drug: Tacrolimus; Drug: Cyclosporine A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00402168

IM103-010

LEA29Y

Details and patient eligibility

About

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

Enrollment: 173 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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173 participants in 2 patient groups

A: Belatacept

Experimental group

Treatment:

Drug: Belatacept

B: calcineurin inhibitor (CNI)-based immunosuppressive regimen

Active Comparator group

Treatment:

Drug: Tacrolimus

Drug: Cyclosporine A