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

Novartis

Status and phase

Completed

Phase 3

Conditions

Renal Transplantation

Treatments

Drug: Everolimus (RAD001)

Study type

Interventional

Funder types

Industry

Identifiers

CRAD001A2306E1

Details and patient eligibility

About

This extension study is designed to provide long-term safety and efficacy data beyond 12 months up to Month 36.

Enrollment

237 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)