CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 115 enrolled
Drug / intervention
Cyclosporine +4 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/NCT01266148
NCT01266148Phase 4Completed
CompareCT.gov

SCHEDULE - Scandinavian Heart Transplant Everolimus de Novo Study With Early CNI Avoidance

Novartis Pharmaceuticals·interventional·Posted Dec 24, 2010·Updated Jun 10, 2015

In Brief

A Phase 4 clinical trial evaluating Cyclosporine, Mycophenolate mofetil, and 3 other interventions for Renal Function and Chronic Allograft Vasculopathy. Completed, enrolled 115 participants across 6 sites in 3 countries.

Detailed Summary

A controlled, randomized, open-label, multicenter study evaluating if early initiation of everolimus and early elimination of cyclosporine in de novo heart transplant recipients can improve long-term renal function and slow down the progression of chronic allograft vasculopathy

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Function and Chronic Allograft Vasculopathy
CountriesDenmark, Norway, Sweden
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 24, 2010
Enrollment StartNov 1, 2009
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 15.5 years ago

Interventions

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.

Everolimusdrug

Everolimus 0.75 mg twice a day as starting dose up to a target blood level: 3-6 ng/mL (7-11 weeks) and 6-10 ng/mL for remaining of study

Anti Thymocyte Globulindrug

Induction therapy, Anti Thymocyte Globulin (ATG): 1-2 mg/kg/day during 3-5 days for control and everolimus groups after transplant surgery and prior to randomization.