Study Evaluating Sirolimus in End Stage Renal Disease in High Risk Kidney Transplant Recipients

NCT ID: NCT00044720

Last Updated: 2009-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 484 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2005-07-31

Brief Summary

The incidence of efficacy failure at 12 months between two regimens.

Conditions

Chronic Kidney Failure; Graft vs Host Disease; Kidney Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Blinding Strategy: NONE

Interventions

Rapamune

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age: 13 years or older, 40 kgs or more
• End-stage renal disease
• African-American/Black transplant recipient and/or repeat renal transplant recipient who lost a previous allograft

Exclusion Criteria

• Evidence of active infection
• Evidence abnormal chest x-ray
• Patients with HIV.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Principal Investigators

Medical Monitor, MD

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

0468H1-101164

Identifier Type: -

Identifier Source: org_study_id