Follow-up Study of Safety of Enteric-Coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A302 - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00149864

Purpose

Aim of study is to collect long term safety data on enteric-coated mycophenolate sodium 720 mg bid in combination with cyclosporine with/without steroids in regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of the study CERL080A302, patients who previously were receiving enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert MMF to 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 Maintenance Renal Transplant Patients

Further study details as provided by Novartis:

Primary Outcome Measures:

To assess the incidence and severity of GI adverse events (AEs) and neutropenia in the first 3 months of treatment in maintenance renal transplant patients.

Secondary Outcome Measures:

Safety/efficacy based on adverse event (AE) reporting.

Estimated Enrollment:	260
Study Start Date:	February 2000

Eligibility

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

Criteria

Inclusion Criteria:

-First cadaveric, living unrelated or living related donor kidney transplant recipients who completed study CERL080A302

Exclusion Criteria:

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149864

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

Responsible Party:	Novartis ( Novartis )
Study ID Numbers:	CERL080A302E
Study First Received:	September 6, 2005
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00149864
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Renal Transplant, adults, immunosuppressant

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