NCT00862979

A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients

A Multi-center, Randomized, Open-label, Parallel Group Study Investigating the Renal Tolerability, Efficacy and Safety of a CNI-free Regimen (Everolimus and MPA) Versus a CNI-regimen With Everolimus in Heart Transplant Recipients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and mycophenolic acid is associated with a better renal outcome as compared to the standard regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while both treatments are expected to be comparable with respect to efficacy.

Detailed description

This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and mycophenolic acid is associated with a better renal outcome as compared to the standard regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while both treatments are expected to be comparable with respect to efficacy.

Conditions

• Heart Transplantation

Interventions

Type	Name	Description
DRUG	Everolimus (EVR)	Everolimus 0.25mg, 0.75mg or 1.0mg based on blood levels (5-10 ng/mL)
DRUG	cyclosporine A (CyA)	10 mg, 25 mg, 50 mg or 100 mg capsule according to blood levels for CNI-regimen group. For CNI-free-regimen dispense on month 6 to 9 only
DRUG	tacrolimus (TAC)	0.5 mg, 1 mg, or 5 mg capsule given according to blood levels for CNI-regimen. For CNI-free-regimen give on month 6 to 9 only
DRUG	Enteric coated mycophenolate sodium (EC-MPS)	180 mg or 360 mg tablet dosed 1440-2280 mg per day
DRUG	mycophenolate mofetil (MMF)	250 mg or 500 mg tablets with a dose of 1500-3000 mg per day
DRUG	Corticosteroids	according to local standard: 0.05-0.3 mg/kg of prednisolone or equivalent

Timeline

• Start date: 2009-02-24
• Primary completion: 2017-03-06
• Completion: 2017-03-06
• First posted: 2009-03-17
• Last updated: 2018-08-07
• Results posted: 2018-06-25

Locations

9 sites across 1 country: Germany