Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Comparison to Mycophenolate Mofetil (MMF) in de Nove Heart Patients

Heart Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574743
• Other study ID #: CERL080A2401
• Status: Completed
• Phase: Phase 4
• First received: December 14, 2007
• Last updated: November 1, 2011
• Start date: January 2002

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationUnited States: Food and Drug AdministrationCanada: Health CanadaArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaGermany: Federal Institute for Drugs and Medical DevicesItaly: Ministry of HealthSpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyIreland: Irish Medicines Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. primary completion date: April 2004
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Transplantation

Intervention

Drug:
• Enteric-coated Mycophenolate Sodium

Locations

Country	Name	City	State
Argentina	Argentina	Buenos Aires
Argentina	Site 1: X5000BJH	Cordoba
Australia	Novartis Investigative site, Sydney, Australia	Sydney
Canada	Novartis Investigative	Edmonton	Alberta
Canada	Novarits	Ottawa
Canada	Novartis	Toronto	Ontario
United States	Novartis Investigative site	Los Angeles	California
United States	University of Minnesota	Minneapolis	Minnesota
United States	Novartis Pharmaceuticals	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,