Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant (BENEFIT-EXT)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Renal Transplantation

Treatments: Drug: Cyclosporin A; Drug: Belatacept Less Intensive Regimen (LI); Drug: Belatacept More Intensive Regimen (MI)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00114777

IM103-027

Details and patient eligibility

About

The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended criteria.

Enrollment: 595 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is a first-time recipient of a kidney transplant from a deceased donor.
• Specific donor criteria

Exclusion criteria

• Donor age <10 years
• Subjects receiving a concurrent solid organ or cell transplant (lung, heart, etc.)
• Subjects with a positive T-cell lymphocytotoxic crossmatch.
• Subjects who are positive for Hepatitis B or C, or HIV
• Active tuberculosis
• History of cancer in the last 5 years
• History of substance abuse
• Specific laboratory results are exclusionary
• Mammography suspicious for cancer
• Allergy to iodine
• For Long-term extension study-Subjects who have completed three years of study treatment (through Week 156)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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595 participants in 3 patient groups

Cyclosporin A

Active Comparator group

Treatment:

Drug: Cyclosporin A

Belatacept Less Intensive Regimen (LI)

Experimental group

Treatment:

Drug: Belatacept Less Intensive Regimen (LI)

Belatacept More Intensive Regimen (MI)

Experimental group

Treatment:

Drug: Belatacept More Intensive Regimen (MI)