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

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149942
• Other study ID #: CERL080ABE01
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2005
• Last updated: November 16, 2016
• Start date: October 2004
• Est. completion date: August 2006

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation
• Liver Transplantation

Intervention

Drug:
• Enteric-coated Mycophenolate sodium (EC-MPS)

Locations

Country	Name	City	State
Switzerland	Novartis	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastro-intestinal adverse events before switch versus 3 months after switch
Secondary	Time to the first biopsy-proven rejection after conversion.
Secondary	Severity of biopsy-proven rejections after conversion.
Secondary	Proportion of patients who had graft loss after conversion.
Secondary	Frequency of adverse events
Secondary	Frequency of infections

External Links

•   Results for CERL080ABE01 from the Novartis Clinical Trials Website