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

Wyeth

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Failure; Graft vs Host Disease; Kidney Transplantation

Treatments: Drug: Rapamune

Study type: Interventional

Funder types: Industry

Identifiers

NCT00044720

0468H1-101164

Details and patient eligibility

About

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

Enrollment: 484 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.