SCHEDULE - Scandinavian Heart Transplant Everolimus de Novo Study With Early Calcineurin Inhibitor (CNI) Avoidance

PHASE4CompletedINTERVENTIONAL
Enrollment

115

Participants

Timeline

Start Date

November 30, 2009

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Renal Function and Chronic Allograft Vasculopathy
Interventions
DRUG

Cyclosporine

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)

DRUG

Mycophenolate mofetil

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

DRUG

Corticosteroids

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.

DRUG

Everolimus

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

DRUG

Anti Thymocyte Globulin

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.

Trial Locations (6)

DK-8200

Novartis Investigative Site, Århus N

DK-2100

Novartis Investigative Site, Copenhagen

0424

Novartis Investigative Site, Oslo

413 45

Novartis Investigative Site, Gothenburg

581 85

Novartis Investigative Site, Linköping

221 85

Novartis Investigative Site, Lund

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY