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:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00149942
First received: September 6, 2005
Last updated: February 1, 2011
Last verified: February 2011

September 6, 2005
February 1, 2011
October 2004
August 2006   (final data collection date for primary outcome measure)
Gastro-intestinal adverse events before switch versus 3 months after switch
Not Provided
Complete list of historical versions of study NCT00149942 on ClinicalTrials.gov Archive Site
  • 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
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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
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

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Kidney Transplantation
  • Liver Transplantation
Drug: Enteric-coated Mycophenolate sodium (EC-MPS)
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
August 2006
August 2006   (final data collection date for primary outcome measure)

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

Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00149942
CERL080ABE01
Not Provided
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Novartis
Not Provided
Study Director: Novartis Novartis
Novartis
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP