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Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A301

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 and tolerability data on enteric-coated mycophenolate sodium with regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of study CERL080A301 study, patients who previously were on enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert from 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: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Open-label Follow-up Study on the Safety of Enteric-coated Mycophenolate Sodium in de Novo Renal Transplant Patients

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Incidence of biopsy proven acute rejection, graft loss, or death in the first six months of treatment.

Secondary Outcome Measures:
  • Incidence of biopsy proven acute rejection in the first six months of treatment in de novo renal transplant recipients.
  • Efficacy of enteric-coated mycophenolate sodium
  • Safety of enteric-coated mycophenolate sodium based on AE reporting.
  • Pharmacokinetics (PK) of enteric-coated mycophenolate sodium (selected centers only).

Enrollment: 246
Study Start Date: December 1999
Study Completion Date: April 2003
Primary Completion Date: April 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
Accepts Healthy Volunteers:   No

Inclusion Criteria:

-First cadaveric, living unrelated or human antigen mismatched living related donor kidney transplant recipients who completed study CERL080A301

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: NCT00149929

Sponsors and Collaborators
Study Director: Novartis Novartis
  More Information

Responsible Party: Novartis Identifier: NCT00149929     History of Changes
Other Study ID Numbers: CERL080A301E
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 September 21, 2017