- Age 13 years and weight 40 kg
- End-stage renal disease, with patients receiving a primary or secondary renal
allograft from a living-unrelated donor, or from a living-related donor.
- Women who are of childbearing potential must have a negative pregnancy test before
enrollment in the study and agree to use a medically acceptable method of
contraception throughout the treatment period and for 3 months following
discontinuation from the study.
- Total white blood cell count 4.0 x 109/L (4,000/mmP3P), platelet count 100 x
10P9P/L(100,000/mmP3P), fasting triglycerides ≤ 4.6 mmol/L (400 mg/dL), fasting
cholesterol ≤ 7.8 mmol/L (300 mg/dL). If it is not possible to obtain fasting
triglycerides and cholesterol before surgery, historical values (within 1 year) may be
used.
- Signed and dated informed consent (parent or legal guardian must provide consent for
patients
age enrolled in the study.
- Evidence of active systemic or localized major infection at the time of initial
Sirolimus administration.
- Cadaveric donors
- 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)
- Use of any investigational drug other than specified in the protocol during the 4
weeks before enrolling in the study.
- Use of planned antibody induction therapy at the time of transplantation.
- Active gastrointestinal disorder that may interfere with drug absorption.
- Known hypersensitivity to Sirolimus, MMF or Cyclosporine or its derivatives.
- Multiple organ transplants (2 or more organ transplant e.g. Kidney and Pancreas).
- Patient with high risk of rejection (eg. Patients with a PRA >50%, black patients and
patients with 2nd transplant who lost their first graft within the first 6 months).
- Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during
pre-study screening