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Extension Study to Assess Tolerability and Safety of Enteric-coated Mycophenolate Sodium in Renal Transplant Recipients Who Received Mycophenolate Mofetil

This study has been completed.
Information provided by:
Novartis Identifier:
First received: October 12, 2005
Last updated: January 28, 2011
Last verified: January 2011
This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.

Condition Intervention Phase
Renal Transplantation
Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A One Arm, Open-label Study to Investigate the Tolerability and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Recipients Who Received Mycophenolate Mofetil (MMF)

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety/tolerability based on adverse events within 6 months after switching patients from MMF to optimized enteric-coated mycophenolate sodium.

Secondary Outcome Measures:
  • Safety based on renal function within 6 months after medication switch.
  • Pharmacokinetics (PK) in a randomized subpopulation.
  • Efficacy measured by the incidence of biopsy-proven acute rejection, graft loss or death within 6 months post medication switch.
  • Efficacy measured by the incidence of biopsy-proven acute rejection 6 months post medication switch.
  • Graft survival and patient survival 6 months post medication switch.

Enrollment: 187
Study Start Date: November 2002
Study Completion Date: April 2005
Primary Completion Date: April 2005 (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/ Exclusion criteria

- Only patients who were participating in study CERL080A2405-DE02 and have completed the first 6 months of the core study can be included in this additional extension study.

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00238966

Sponsors and Collaborators
Study Director: Novartis Novartis
  More Information Identifier: NCT00238966     History of Changes
Other Study ID Numbers: CERL080A2405DE02E1
Study First Received: October 12, 2005
Last Updated: January 28, 2011

Keywords provided by Novartis:
Renal transplantation, Enteric-Coated Mycophenolate Sodium (EC-MPS)

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 May 22, 2017