At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 95 enrolled

Drug / intervention

Everolimus +3 moredrug

Likely dose

Mycophenolate mofetil 3000 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02864706

NCT02864706Phase 4Completed

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5, 6 or 7 Year Follow-up Control After the SCHEDULE Study (SCANDINAVIAN HEART TRANSPLANT EVEROLIMUS DE NOVO STUDY WITH EARLY CNI AVOIDANCE)

Novartis Pharmaceuticals·interventional·Posted Aug 12, 2016·Updated Oct 3, 2019

In Brief

A Phase 4 clinical trial evaluating Everolimus, Cyclosporine, and 2 other interventions for Heart Transplantation. Completed, enrolled 95 participants across 6 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHeart Transplantation

CountriesDenmark, Norway, Sweden

Collaborators--

Timeline

Phase 4CompletedFinished

20162017201820192020202120222023202420252026

Enrollment StartJan 2016

First PostedAug 2016

Primary CompletionSep 2017

TodayJul 2026

First PostedAug 12, 2016

Enrollment StartJan 18, 2016

Primary CompletionSep 25, 2017

TodayJul 2, 2026

Enrollment to primary: 1.7 yearsPosted 9.9 years ago

Interventions

Everolimusdrug

All patients, independent of their initial randomization in the core study, were followed up as in one single group Commercially available everolimus (Certican®), oral route, was used.

Cyclosporinedrug

Cyclosporine (CsA) control group target blood level: 150-350 ng/mL (month 1-3); 100-250 ng/mL (month 4-6); 60-200 ng/mL (month 7-12); everolimus group target blood level: 75-175 ng/mL (month 1-3)

Mycophenolate mofetildrug

Mycophenolate mofetil (MMF) target dose for control group: 2000-3000 mg/day everolimus group target dose: 1500-2000 mg/day and 75-175 ng/mL after week 11

Corticosteroidsdrug

Corticosteroids (CS) initiated at 0.2-0.5 mg/kg/day. Tapered to no less than 0.1 mg/kg at Month 3 for control and everolimus groups.