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

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00470665
• Collaborator: (none)
• Enrollment: 460
• Duration (Months): 23

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Allograft Recipients	Drug: Rapamune	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: An Open-Label, Concentration-Controlled, Randomized, 12-Month Study of Prograf + Rapamune + Corticosteroids Compared to Cyclosporine,USP (Modified) + Rapamune + Corticosteroids in High Risk Renal Allograft Recipients
• Study Start Date: Aug 1, 2002
• Study Completion Date: Jul 1, 2004

Outcome Measures

Primary Outcome Measures

1. 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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00470665
• Other Study ID Numbers: 0468H1-903
• First Posted: May 8, 2007
• Last Update Posted: May 8, 2007
• Last Verified: May 1, 2007

• Additional relevant MeSH terms: Sirolimus

Study Results

No Results Posted as of May 8, 2007