Study Evaluating Rapamune® Maintenance Regimen

Wyeth

Status and phase

Completed

Phase 3

Conditions

Renal Transplant

Treatments

Drug: Sirolimus (Rapamune®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00478608

0468E-102362

Details and patient eligibility

About

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 :

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

Enrollment

79 patients

Sex

All

Ages

13+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age greater than or equal to 13 years of age.
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.
Patients with a panel of reactive antibody (%PRA) less than or equal to 50%

Exclusion criteria

Evidence of active systemic or localized major infection at the time of initial sirolimus administration.
Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening.
Chronic anti-arrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery.
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).
Current treatment with partial opioid agonists (eg, buprenorphine) or combination agonists/antagonists.