Study Evaluating Sirolimus in Kidney Transplant Recipients in India

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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