NCT00574743

Brief Summary

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

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
4 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 17, 2007

Completed
Last Updated

November 2, 2011

Status Verified

November 1, 2011

Enrollment Period

2.2 years

First QC Date

December 14, 2007

Last Update Submit

November 1, 2011

Conditions

Heart Transplantation

Keywords

ERL080A, Heart Transplantation, Mycophenolate, EC-MPS

Study Arms (2)

2

NO INTERVENTION

1

ACTIVE COMPARATOR
Drug: Enteric-coated Mycophenolate Sodium

Interventions

Enteric-coated Mycophenolate SodiumDRUG
1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Novartis Investigative site

Los Angeles, California, 90073, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Novartis Pharmaceuticals

Philadelphia, Pennsylvania, 19103, United States

Location

Argentina

Buenos Aires, 1107, Argentina

Location

Site 1: X5000BJH

Córdoba, Argentina

Location

Novartis Investigative site, Sydney, Australia

Sydney, Australia

Location

Novartis Investigative

Edmonton, Alberta, T6G 2B7, Canada

Location

Novartis

Toronto, Ontario, M5G 2C4, Canada

Location

Novarits

Ottawa, K1H 8L6, Canada

Location

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2007

First Posted

December 17, 2007

Study Start

January 1, 2002

Primary Completion

April 1, 2004

Last Updated

November 2, 2011

Record last verified: 2011-11

Locations

AR(2)US(3)AU(1)CA(3)