Renal Allograft Recipients
Conditions
Brief summary
The purpose of this study is to assess whether in high-risk kidney transplant patients (patients whose previous kidney transplant failed, have a high PRA lab test result or are of African-American descent) that a combination of Rapamune with Prograf and steroids will prevent acute rejection as well as Rapamune and cyclosporine and steroids.
Interventions
DRUGRapamune
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of African-American descent or patient with a history of multiple transplants and/or patients with a high panel reactive antibody lab test with a renal transplant from a cadaveric donor, a living unrelated donor or a living-related mismatched donor. * Age \>= 13 years, weight \>= 40 kg * Women must have a negative pregnancy test at study entry
Exclusion criteria
* Multiple organ transplants or double kidney transplants (pediatric en-bloc or double adult) * Active systemic infection, or localized major infection or known HIV * Patients with residual kidney function \>20 mL/min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First biopsy-confirmed acute rejection, patient death or graft loss in the first 12 months following transplantation. First occurence of kidney graft loss or patient death in the first 12 months following transplantation. | — |
Outcome results
None listed