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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00574743




Registration number
NCT00574743
Ethics application status
Date submitted
14/12/2007
Date registered
17/12/2007
Date last updated
2/11/2011

Titles & IDs
Public title
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Comparison to Mycophenolate Mofetil (MMF) in de Nove Heart Patients
Scientific 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
Secondary ID [1] 0 0
CERL080A2401
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Transplantation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Enteric-coated Mycophenolate Sodium

No Intervention: 2 -

Active Comparator: 1 -


Treatment: Drugs: Enteric-coated Mycophenolate Sodium
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
162
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative site, Sydney, Australia - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
Argentina
State/province [4] 0 0
Buenos Aires
Country [5] 0 0
Argentina
State/province [5] 0 0
Cordoba
Country [6] 0 0
Canada
State/province [6] 0 0
Alberta
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Ottawa

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the safety and efficacy of EC-MPS (ERL080) in comparison to MMF in
de novo heart recipients.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00574743
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis
Address 0 0
Novartis
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00574743