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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Page 1 of 11 (44 locations)

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