Extension Study of Enteric-Coated Mycophenolate Sodium With Short-Term or no Steroid Use Compared With Enteric-Coated Mycophenolate Sodium With Standard Steroid Therapy in de Novo Kidney Recipients

This study is ongoing, but not recruiting participants.

First Received: October 14, 2005 Last Updated: September 17, 2008 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00240955

Purpose

The objective of this study is to assess the long-term safety and tolerability of EC-MPS on the patients who completed the core study and wish to continue treatment on EC-MPS.

Condition	Intervention	Phase
Renal Transplantation	Drug: Enteric-coated Mycophenolate sodium (EC-MPS)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Two Immunosuppressive Regimens Mycophenolate Sodium (EC-MPS) With Short-Term Steroid Use or Free of Steroids Compared With a Regimen of EC-MPS With Standard Steroids in de Novo Kidney Recipients

Resource links provided by NLM:

Drug Information available for: Mycophenolate sodium Mycophenolate mofetil hydrochloride Mycophenolate Mofetil

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Safety and tolerability of enteric-coated mycophenolate sodium based on adverse event (AE) reporting.

Estimated Enrollment:	80
Study Start Date:	February 2004

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria/ Exclusion Criteria

All patients who completed the core study and who are still receiving the EC-MPS and wish continue treatment with EC-MPS and from whom written informed consent has been obtained

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240955

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

No publications provided

Study ID Numbers:	CERL080A2404E1
Study First Received:	October 14, 2005
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00240955 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Novartis:

Renal/Kidney, Transplantation, steroids, EC-MPS

Study placed in the following topic categories:

Immunologic Factors
Mycophenolate mofetil
Immunosuppressive Agents

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Mycophenolate mofetil
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009