Extension Study of the Safety and Efficacy of Enteric-Coated Mycophenolate Sodium in Kidney Transplant Recipients - Full Text View

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

This study is ongoing, but not recruiting participants.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00241059

Purpose

The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405LA01) to continue on the same treatment and to assess the long-term safety of EC-MPS.

Condition	Intervention	Phase
Renal Transplantation	Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)	Phase IV

MedlinePlus related topics:

Kidney Transplantation

ChemIDplus related topics:

Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Mycophenolate sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	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

Further study details as provided by Novartis:

Primary Outcome Measures:

Safety parameters and graft function in maintenance renal transplant recipients.

Secondary Outcome Measures:

Incidence of acute rejection episodes and graft survival in maintenance renal transplant recipients.

Estimated Enrollment:	260
Study Start Date:	November 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

All patients who completed study CERL080A2405-LA01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.

Exclusion Criteria:

Other protocol-defined inclusion / exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241059

Sponsors and Collaborators

Novartis

Investigators


Study Director:	Novartis	Novartis

More Information

Study ID Numbers:	CERL080A2405LA01E1
First Received:	October 14, 2005
Last Updated:	March 18, 2008
ClinicalTrials.gov Identifier:	NCT00241059
Health Authority:	Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Novartis:

Renal transplantation, maintenance patients, tolerability, EC-MPS

Study placed in the following topic categories:

Mycophenolate mofetil

Additional relevant MeSH terms:

Immunologic Factors

Physiological Effects of Drugs

Immunosuppressive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008