This is a Two-year Follow-up Study to Evaluate the Long-term Safety, Tolerability and Efficacy of 2 Different Doses of Everolimus
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A 2-year Extension to a 1-year Multicenter, Randomized, Open Label, Parallel Group Study of the Safety, Tolerability and Efficacy of Two Doses (1.5 and 3 mg/Day) of Everolimus With Steroids and Optimized Administration of Cyclosporine in de Novo Renal Transplant Recipients.
Study Start Date
Actual Primary Completion Date
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• To assess the incidence of graft loss, death, biopsy-proven acute rejection, antibody-treated acute rejection, biopsy-proven chronic allograft nephropathy, retransplantation or dialysis up to 36 months
Secondary Outcome Measures
To quantify the incidence of biopsy-proven acute rejection episodes, graft loss, death or lost to follow-up at 6, 12, 24 and 36 months in both groups. To assess the incidence of graft loss, death, biopsy-proven acute rejection,
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Patients who are receiving study medication at Month 12 of the one-year study (CRAD001A2306) and sign a new Informed Consent to extend the treatment and observation period beyond Month 12.
Females patients must agree to continue using an approved method of birth control throughout the study and for 3 months following the last dose of study medication.
Another Informed Consent was required for the extension amendment. This Informed Consent allowed for separate consent to the amendment study itself, and the retrospective collection of biopsies and/or the yearly protocol biopsies
Inclusion and exclusion criteria were not changed, except that patients who completed the core study in follow-up became eligible to participate in the amended extension.
Patients who are receiving study medication and do not sign a new Informed Consent to extend the treatment and observation period beyond Month 12 RAD001A2306)