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Extension Study of the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients

This study has been completed.
Information provided by:
Novartis Identifier:
First received: October 14, 2005
Last updated: January 28, 2011
Last verified: January 2011
The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405LA01) to continue on the same treatment and to assess the long-term safety of EC-MPS.

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 Prospective, Open-label, Multicenter, International Follow-up Study on the Safety and Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety parameters and graft function in maintenance renal transplant recipients.

Secondary Outcome Measures:
  • Incidence of acute rejection episodes and graft survival in maintenance renal transplant recipients.

Enrollment: 183
Study Start Date: August 2002
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EC-MPS arm Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients who completed study CERL080A2405-LA01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.

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: NCT00241059

Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis
  More Information

Responsible Party: External Affairs, Novartis Pharmaceticals Identifier: NCT00241059     History of Changes
Other Study ID Numbers: CERL080A2405LA01E1
Study First Received: October 14, 2005
Last Updated: January 28, 2011

Keywords provided by Novartis:
Renal transplantation, maintenance patients, tolerability, 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 25, 2017