Extension Study on the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients

January 28, 2011 updated by: Novartis

A Prospective, Open-label, Multicenter, International Follow-up Study on the Safety and Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients

This extension study is to assess the long-term safety of EC-MPS

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion / Exclusion Criteria - All patients who completed study CERL080A2405-IN01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.

Other protocol-defined inclusion / exclusion criteria may apply

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To assess patient and graft survival, acute rejection incidence, graft function and specific pertinent safety parameters in de novo renal transplant recipients.

Secondary Outcome Measures

Outcome Measure
To assess the respective influence of parameters (demographic characteristics, transplant-related variables, medical conditions and post-transplantation complications) on clinical outcomes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

October 12, 2005

First Submitted That Met QC Criteria

October 12, 2005

First Posted (Estimate)

October 14, 2005

Study Record Updates

Last Update Posted (Estimate)

January 31, 2011

Last Update Submitted That Met QC Criteria

January 28, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CERL080A2405IN01E1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

3
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