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

• Status: Completed
• Trial end date: 2004-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Everolimus; Sirolimus; Tacrolimus

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