This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Conversion Trial From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering From Gastrointestinal (GI) Adverse Events While on Mycophenolate Mofetil Therapy (MMF) Therapy

This study has been completed.
Information provided by:
Novartis Identifier:
First received: September 6, 2005
Last updated: November 16, 2016
Last verified: November 2016
This open, single arm, explorative study aims to investigate the evolution of gastrointestinal adverse events after switch from MMF to EC-MPS in organ transplanted patients suffering from gastrointestinal adverse events while on MMF therapy.

Condition Intervention Phase
Kidney Transplantation Liver Transplantation Drug: Enteric-coated Mycophenolate sodium (EC-MPS) Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Conversion Trial From Mycophenolate Mofetil (MMF) to Enteric-Coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering From GI Adverse Events While on Mycophenolate Mofetil Therapy

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Gastro-intestinal adverse events before switch versus 3 months after switch

Secondary Outcome Measures:
  • Time to the first biopsy-proven rejection after conversion.
  • Severity of biopsy-proven rejections after conversion.
  • Proportion of patients who had graft loss after conversion.
  • Frequency of adverse events
  • Frequency of infections

Enrollment: 23
Study Start Date: October 2004
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Kidney or liver transplanted patients
  • Currently under MMF therapy and currently suffering from upper or lower gastro-intestinal adverse events

Exclusion Criteria:

  • Recent graft rejection before the study
  • Other pre-existing conditions that may cause gastro-intestinal complaints
  • Use of other drugs known to cause gastro-intestinal complaints

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: NCT00149942

Basel, Switzerland
Sponsors and Collaborators
Study Director: Novartis Novartis
  More Information

Additional Information: Identifier: NCT00149942     History of Changes
Other Study ID Numbers: CERL080ABE01
Study First Received: September 6, 2005
Last Updated: November 16, 2016

Keywords provided by Novartis:
Enteric coated mycophenolate sodium
gastrointestinal adverse events
Kidney and liver transplantation patients experiencing GI AEs with current MMF treatment

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