Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Transplantation
Keywords: Heart Transplantation
Cardiac Transplantation
CNI-sparing
renal function
CNI
Cyclosporine A
Everolimus
mycophenolic acid
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-03-17
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18
timeFrame: Month 18
Secondary outcomes:
measure: Occurrence of Treatment Failures From Month 6 to 9 and Month 9 to 18
timeFrame: Month 6 to Month 9; Month 9 to Month 18
measure: Occurrence of Major Cardiac Events (MACE) From Month 6 to 18
timeFrame: Month 6 to Month 18
measure: Calculated Glomerular Filtration Rate (cGFR) According to Cockcroft-Gault at Month 12 and 18
timeFrame: Month 12 and 18
measure: Serum Creatinine at Month 6, 8, 9, 10 12 and 18
timeFrame: Month 6, 8, 9, 10 12 and 18
measure: Reciprocal Creatinine Slope Between Month 6 and Month 18
timeFrame: Between Month 6 and Month 18
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Regensburg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: