This is a Two-year Follow-up Study to Evaluate the Long-term Safety, Tolerability and Efficacy of 2 Different Doses of Everolimus

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00531063
• Date of registration: 17/09/2007
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: This is a Two-year Follow-up Study to Evaluate the Long-term Safety, Tolerability and Efficacy of 2 Different Doses of Everolimus
• Scientific title: 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.
• Date of first enrolment: November 2001
• Target sample size: 237
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00531063
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

Switzerland

Contacts

• Name: Novartis
• Affiliation: Novartis

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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)



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Renal Transplantation

Intervention(s)

Drug: Everolimus (RAD001)

Primary Outcome(s)

• 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(s)

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,

Secondary ID(s)

CRAD001A2306E1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors