The Safety and Efficacy of Belatacept, Daclizumab, and Sirolimus in Recipients of Non-HLA-Identical Living-Donor Renal Transplants (ITN023ST)
Drugs that suppress the immune system, have contributed to increased success of
transplantation. However, to prevent organ rejection, transplant recipients need to take
immunosuppressive drugs for the rest of their lives; these drugs make patients more
susceptible to infection and certain kinds of cancer. Belatacept is an experimental
medication that specifically targets immune reactions against transplanted organs and has
been shown to be effective in preventing kidney transplant rejection in previous clinical
trials. Both thymoglobulin, an antibody, and sirolimus, an anti-rejection drug, prevent
rejection by lowering the response of the immune system to the transplanted organ. This
study will evaluate whether belatacept, along with thymoglobulin and sirolimus, is safe in
kidney transplant patients. The study will also evaluate this regimen's potential to allow
tapering and eventual discontinuation of all immunosuppressive drugs.
This study will last up to 4 years. At the time of transplant, participants will begin a
medication schedule consisting of thymoglobulin, sirolimus, and belatacept. Participants
will receive infusions of thymoglobulin on days 1 through 4, and a combination of oral
sirolimus (daily) and belatacept infusions at day 5, then weeks 2, 4, 8, and monthly for at
least 2 years. Dose reduction of belatacept will occur at 12 weeks post-transplant. At Year
2, eligible participants may choose to begin drug withdrawal or continue study therapy
through the end of the study. Study visits will occur weekly for the first two months, then
monthly. These visits will include belatacept treatment, general medical assessments, blood
and urine collection, and other assessments to determine overall health of the recipient's
immune system and kidney transplant and to better understand the way the immune system works
in the acceptance or rejection of organ transplants.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Acute Rejection at 6-Months
Cumulative incidence of acute rejection[1] at 6 months post-transplant based on local pathology biopsy reads Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
6 months post-transplant
Yes
Flavio Vincenti, MD
Principal Investigator
University of California, San Francisco
United States: Food and Drug Administration
DAIT ITN023ST
NCT00346151
December 2006
February 2010
Name | Location |
---|---|
University of California, San Francisco | San Francisco, California 94143 |
Emory University | Atlanta, Georgia 30322 |