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

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 of this treatment will also be studied

Official Title

Belatacept Conversion Trial in Renal Transplantation

Conditions

Renal Transplant

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• The change in calculated glomerular filtration rate (GFR) [Time Frame: from baseline to 12 months post randomization]

Secondary Outcome Measures:

• Assess the incidence/severity of acute rejection [Time Frame: At 6 and 12 months]
• death and graft loss
• discontinuation or dose alteration due to declining renal function
• quality of life and overall safety and tolerability of a belatacept-based immunosuppression regimen

Study Start

December 2006

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

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

Exclusion Criteria:

• Significant infection
• acute rejection within 3 months
• prior graft loss due to rejection
• pregnancy
• positive crossmatch

Total Enrolment

170

Contact Details

For further site information, please email: Clinical.Trials@bms.com (First line of email MUST contain “NCT00402168” & Site#)

• Site 006: Woodville, South Australia, 5011, Australia; Recruiting
• Site 007: Parkville, Victoria, 3050, Australia; Recruiting
• Site 008: Sydney, New South Wales, 2145, Australia; Not yet recruiting

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