SCHEDULE Follow Up Visit 5-7 yr

• Status: Completed
• Trial end date: 2017-09-25
• Target enrollment: 0
• Participant gender: All

Summary

The major aim of this extension study was to evaluate the long-term effect (i.e. 5 to 7 years) of early initiation of everolimus and early elimination of CsA compared to standard immunosuppressive regimen including CsA on primary and secondary endpoints investigated in the SCHEDULE (NCT01266148) main study.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Cyclosporine; Cyclosporins; Everolimus; Mycophenolic Acid; Sirolimus

Criteria

Inclusion Criteria:

• Patients who participated in the SCHEDULE 12-month main study, and who completed the 3 year follow-up visit

• Patients who are coming for a regular annual clinic visit 5 to 7 years after randomization in the main study

• Obtaining of a separate signed patient informed consent will be required for participation in this follow-up examination.

Exclusion Criteria:

• Patients with a retransplanted heart since the original SCHEDULE study