Status:
COMPLETED
Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Renal Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- Subject is a first-time recipient of a kidney transplant from a deceased donor.
- Specific donor criteria
Exclusion
- 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)
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
595 Patients enrolled
Trial Details
Trial ID
NCT00114777
Start Date
February 1 2005
End Date
September 1 2014
Last Update
July 7 2017
Active Locations (79)
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1
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
2
Ucla Kidney & Kidney-Pancreas Transplant Research Office
Los Angeles, California, United States, 90024
3
National Institute Of Transplantation
Los Angeles, California, United States, 90057
4
Sharp Memorial Hospital
San Diego, California, United States, 92133