Clinical trial NCT00574743: Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Comparison to Mycophenolate Mofetil (MMF) in de Nove Heart Patients
Official title: A 12-month, Single-blind, Randomized, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of ERL080A Compared With MMF in de Novo Heart Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Transplantation
Keywords: ERL080A, Heart Transplantation, Mycophenolate, EC-MPS
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-12-17
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of EC-MPS (ERL080) in comparison to MMF in de novo heart recipients.


Eligibility criteria: Inclusion criteria

* Male or female cardiac patients 18-65 years old undergoing primary heart transplantation treated with CS-ME and corticosteroids as basic immunosuppression.
* Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment. Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility.
* Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.

Exclusion criteria

* Patients with donor hearts greater than 60 years of age and/or with cold ischemia time of more than 6 hours and/or donor hearts which have obvious coronary disease or are known to have heart disease at time of transplant.
* Patients on Left Ventricular Assist Device who have received any immunotherapy prior to transplantation or who are scheduled to receive immunotherapy thereafter.
* Patients with Panel Reactive Antibodies (PRA) 25%.
* Patients with serum creatinine 3.0mg/dL..
* Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.
* Patients with a history of significant coagulopathy or medical condition requiring long term anti-coagulation after transplantation (low aspirin treatment is allowed).

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Novartis Investigative site
state: California
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Philadelphia
country: United States
facility: Novartis Pharmaceuticals
state: Pennsylvania
city: Buenos Aires
country: Argentina
facility: Argentina
city: Cordoba
country: Argentina
facility: Site 1: X5000BJH
city: Sydney
country: Australia
facility: Novartis Investigative site, Sydney, Australia
city: Edmonton
country: Canada
facility: Novartis Investigative
state: Alberta
city: Toronto
country: Canada
facility: Novartis
state: Ontario
city: Ottawa
country: Canada
facility: Novarits
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References: