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

Novartis

Status and phase: Completed; Phase 4

Conditions: Heart Transplantation

Treatments: Drug: Corticosteroids; Drug: tacrolimus (TAC); Drug: Enteric coated mycophenolate sodium (EC-MPS); Drug: cyclosporine A (CyA); Drug: Everolimus (EVR); Drug: mycophenolate mofetil (MMF)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00862979

CRAD001ADE14

2007-002671-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Heart transplantation, 3 months prior to enrollment
• Patients have to receive an immunosuppressive regimen with Sandimmun® Optoral, Certican® and corticosteroids
• Sufficient graft function
• Sufficient renal function
• Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at baseline, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility

Exclusion criteria

• Multi-organ recipients, re-transplantation, or previous transplant with any other organ.
• Patients who are recipients of A-B-O incompatible transplants
• Cold ischemia time >6 hours
• Historical or current peak PRA of > 25% at time of transplantation
• Already existing antibodies against the HLA-type of the receiving transplant Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

CNI-regimen

Active Comparator group

Description:

CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids

Treatment:

Drug: Everolimus (EVR)

Drug: cyclosporine A (CyA)

Drug: Corticosteroids

Drug: tacrolimus (TAC)

CNI-free-regimen

Experimental group

Description:

CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids

Treatment:

Drug: mycophenolate mofetil (MMF)

Drug: Everolimus (EVR)

Drug: cyclosporine A (CyA)

Drug: Corticosteroids

Drug: Enteric coated mycophenolate sodium (EC-MPS)

Drug: tacrolimus (TAC)