Study Comparing Sirolimus/Prograf vs Sirolimus/CsA in High-Risk Renal Transplant Recipients

Wyeth

Status and phase

Completed

Phase 3

Conditions

Renal Allograft Recipients

Treatments

Drug: Rapamune

Study type

Interventional

Funder types

Industry

Identifiers

NCT00470665

0468H1-903

Details and patient eligibility

About

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.

Sex

All

Ages

13+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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