Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant

Completed · Phase 3

Conditions studied: Renal Transplantation

In brief

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.

Key facts

Study ID

NCT00114777

Run by

Bristol-Myers Squibb

People needed

595

Starts

2005-02-01

Expected to finish

2014-09-01

Last updated by the study team

2017-07-07

Who can join

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

You may qualify if…

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

You may not qualify if…

• 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)

Where it is running

• University Of Wisconsin — Madison, Wisconsin, United States
• Froedtert Memorial Hospital — Milwaukee, Wisconsin, United States
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — Cordoba, Crd, Córdoba Province, Argentina
• Local Institution — Rosario, Santa Fe Province, Argentina
• Local Institution — Santa Fe, Argentina
• Local Institution — Woodville, South Australia, Australia
• Local Institution — Innsbuck, Austria
• Local Institution — Vienna, Austria
• Local Institution — Leuven, Belgium
• Local Institution — Porto Alegre, Rio Grande do Sul, Brazil
• Local Institution — Porto Alegre/rs, Rio Grande do Sul, Brazil
• Local Institution — Campinas/sp, São Paulo, Brazil
• Local Institution — Rio de Janeiro, Brazil
• Local Institution — São Paulo, Brazil
• Local Institution — São Paulo, Brazil
• Local Institution — Edmonton, Alberta, Canada
• Local Institution — Halifax, Nova Scotia, Canada
• Local Institution — Montreal, Quebec, Canada
• Local Institution — Saskatoon, Saskatchewan, Canada
• Local Institution — Santiago, Santiago Metropolitan, Chile
• Local Institution — Prague, Czechia
• Local Institution — Bordeaux, France
• Baylor University Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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