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
Endpoint Classification: Safety Study
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 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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Renal Transplant, adults, immunosuppressant

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 26, 2016