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Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A302

This study has been completed.
Information provided by:
Novartis Identifier:
First received: September 6, 2005
Last updated: February 1, 2011
Last verified: February 2011
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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Open-label Follow-up Study on the Safety of Enteric-coated Mycophenolate Sodium in Maintenance Renal Transplant Patients

Resource links provided by NLM:

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.

Enrollment: 264
Study Start Date: February 2000
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All

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
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Please refer to this study by its identifier: NCT00149864

Sponsors and Collaborators
Study Director: Novartis Novartis
  More Information

Responsible Party: Novartis Identifier: NCT00149864     History of Changes
Other Study ID Numbers: CERL080A302E
Study First Received: September 6, 2005
Last Updated: February 1, 2011

Keywords provided by Novartis:
Renal Transplant, adults, immunosuppressant

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on August 16, 2017