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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

Bristol-Myers Squibb (BMS) logo

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)

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

Trial contacts and locations

44

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Data sourced from clinicaltrials.gov

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