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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00149929
First Posted: September 8, 2005
Last Update Posted: February 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  Purpose
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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149929


Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00149929     History of Changes
Other Study ID Numbers: CERL080A301E
First Submitted: September 6, 2005
First Posted: September 8, 2005
Last Update Posted: February 2, 2011
Last Verified: February 2011

Keywords provided by Novartis:
Renal Transplant, adults, immunosuppressant

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action