Follow-up Study of Safety of Enteric-Coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A0107

This study is ongoing, but not recruiting participants.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00149916

Purpose

Aim of study is to provide safety and tolerability data on enteric-coated mycophenolate sodium in regard to adverse events, serious adverse events and patient and graft survival. After successful completion of the study CERL080A0107 study, patients could continue to receive enteric-coated mycophenolate sodium.

Condition	Intervention	Phase
Renal Transplant	Drug: Mycophenolate sodium (enteric coated)	Phase III

MedlinePlus related topics: Kidney Transplantation

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Multicenter, Open-Label Follow-up Study on the Safety of Enteric-Coated Mycophenolate Sodium in Renal Transplant Patients.

Further study details as provided by Novartis:

Primary Outcome Measures:

To assess gastro-intestinal tolerability

Secondary Outcome Measures:

Efficacy/safety of enteric-coated mycophenolate sodium based on AE reporting.

Estimated Enrollment:	150
Study Start Date:	March 2000

Eligibility

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

Criteria

Inclusion Criteria:

Cadaveric or living donor kidney transplant recipients who completed the study CERL080A0107

Exclusion Criteria:

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149916

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

Responsible Party:	Novartis ( Novartis )
Study ID Numbers:	CERL080A107E
Study First Received:	September 6, 2005
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00149916
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Renal Transplant, adults, immunosuppressants

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 January 16, 2009