SCHEDULE Follow Up Visit 5-7 yr (CRAD001ANO05)

Novartis

Status and phase: Completed; Phase 4

Conditions: Heart Transplantation

Treatments: Drug: Everolimus; Drug: Cyclosporine; Drug: Corticosteroids; Drug: Mycophenolate mofetil

Study type: Interventional

Funder types: Industry

Identifiers

NCT02864706

CRAD001ANO05

2016-000404-28 (EudraCT Number)

CRAD001ANO026YFU (Other Identifier)

Details and patient eligibility

About

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.

Full description

This protocol was written to describe the procedures for a single 5, 6 or 7 year follow-up control visit of patients who participated in the 12-month SCHEDULE (NCT01266148) study and the following 3-year follow-up examination/visit. The aim of this 5 to 7-year follow-up visit was to examine the effect of long term treatment, i.e. 5, 6 or 7 years, with early initiation of everolimus (Certican®) and early elimination of cyclosporine (CsA), compared to standard immunosuppressive regimen including CsA, on renal and heart function. During the time period of this follow-up examinations, this visit was performed as part of a routine annual visit 5, 6 or 7 years since transplantation (and inclusion in the original SCHEDULE study).

Study code of SCHEDULE, the core study: CRAD001ANO02 (EudraCT No.: 2009-013074-41)

Enrollment: 95 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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95 participants in 2 patient groups

EVEROLIMUS

Experimental group

Description:

patients received everolimus (Certican), low-exposure CsA (Neoral), mycophenolate mofetil (MMF) and corticosteroids with CsA withdrawal after 7-11 weeks

Treatment:

Drug: Everolimus

Control

Active Comparator group

Description:

patients received standard CsA, MMF and corticosteroids

Treatment:

Drug: Corticosteroids

Drug: Mycophenolate mofetil

Drug: Cyclosporine