Study Evaluating Rapamune® Maintenance Regimen

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients.

Secondary :

1. To evaluate the safety of sirolimus over 12 months after transplantation in Korean renal transplantation recipients.

2. To evaluate graft function, patient survival and graft survival at 6 and 12 months after transplantation, and to investigate the incidence of biopsy-confirmed acute rejection episode at 12 months after transplantation.

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

Details

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

Criteria

Inclusion Criteria:

1. Age greater than or equal to 13 years of age.

2. End-stage renal disease in patients scheduled to receive a primary renal allograft from a cadaveric donor, a living-unrelated donor, or from a living-related (excluding 0 antigen mismatch) donor. A mismatch donor is defined as a donor human leukocyte antigen (HLA) antigen not shared by the patient.

3. Patients with a panel of reactive antibody (%PRA) less than or equal to 50%

Exclusion Criteria:

1. Evidence of active systemic or localized major infection at the time of initial sirolimus administration.

2. Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening.

3. Chronic anti-arrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery.

4. History of malignancy within 5 years before enrollment into the study (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin).

5. Current treatment with partial opioid agonists (eg, buprenorphine) or combination agonists/antagonists.