Study Evaluating Sirolimus in Kidney Transplant Recipients in India

A Post Marketing Surveillance Looking at Safety of Rapamune (Sirolimus) in Indian Population Undergoing de Novo Renal Transplantation.

To determine the safety of sirolimus tablets in renal allograft recipients in a postmarketing surveillance setting.

Inclusion Criteria:

• Patients in End Stage Renal Disease who are above 13 years of age and weigh more than 40 kilograms.
• Patients scheduled to receive a kidney from a cadaveric donor, from a living unrelated donor or from a living related donor.

Exclusion Criteria:

• Evidence of major infections at the time of sirolimus administration
• Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the treatment phase.
• Females who are pregnant, breast feeding or in reproductive age group and not using a medically acceptable form of contraception