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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00149942
First Posted: September 8, 2005
Last Update Posted: November 18, 2016
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
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)
  Eligibility

Information from the National Library of Medicine

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

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
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): NCT00149942


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

Additional Information:
ClinicalTrials.gov Identifier: NCT00149942     History of Changes
Other Study ID Numbers: CERL080ABE01
First Submitted: September 6, 2005
First Posted: September 8, 2005
Last Update Posted: November 18, 2016
Last Verified: November 2016

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

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