Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)

Completed · Phase 3

Conditions studied: Kidney Transplantation, Chronic Kidney Failure

In brief

The purpose of this study is to learn if Belatacept can provide protection from organ rejection following kidney transplantation while avoiding some of the toxic effects of standard immunosuppressive medications such as kidney damage. Effects on kidney function and patient survival as well as drug safety will also be studied.

Key facts

Study ID

NCT00256750

Run by

Bristol-Myers Squibb

People needed

738

Starts

2005-03-01

Expected to finish

2015-04-01

Last updated by the study team

2016-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject is a recipient of a living donor or deceased donor kidney transplant.
• Male or Female, 18 or older

You may not qualify if…

• First time recipient, PRA >- 50% or for retransplantation PRA >- 30%.
• If retransplantation, previous graft loss cannot be due to acute rejection.
• Positive cross match.
• Subject receiving extended criteria donor (ECD) organ
• For Long-term extension study-Subjects who have completed three years of study treatment (through Week 156)

Where it is running

• Loma Linda University Medical Center-Transplantation Institu — Loma Linda, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• California Institute Of Renal Research — San Diego, California, United States
• University Of California San Francisco Medical Center — San Francisco, California, United States
• University Of Colorado Health Sciences Center — Aurora, Colorado, United States
• Yale University School Of Medicine-Yale New Haven Hospital — New Haven, Connecticut, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Medical College Of Georgia — Augusta, Georgia, United States
• University Of Chicago Hospitals — Chicago, Illinois, United States
• University Of Iowa Hospitals And Clinics — Iowa City, Indiana, United States
• University Of Kentucky — Lexington, Kentucky, United States
• Maine Tranplant Program — Portland, Maine, United States
• Western New England Renal & Transplant Associates, Pc — Springfield, Massachusetts, United States
• Henry Ford Hospital, Transplant Institute — Detriot, Michigan, United States
• University Of Minnesota — Minneapolis, Minnesota, United States
• Washington University School Of Medicine — St Louis, Missouri, United States
• Recanati/Miller Transplantation Institute — New York, New York, United States
• Columbia University College Of Physicians & Surgeons — New York, New York, United States
• University Of Rochester Medical Center — Rochester, New York, United States
• University Of North Carolina At Chapel Hill — Chapel Hill, North Carolina, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Div Of Multi-Organ Trans, Hepato-Biliary-Pancreatic Surgery — Philadelphia, Pennsylvania, United States
• University Of Alabama At Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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