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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00149942

Enrollment

Registered

2005-09-08

Start date

2004-10-31

Completion date

2006-08-31

Last updated

2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation, Liver Transplantation

Keywords

Enteric coated mycophenolate sodium, transplantation, gastrointestinal adverse events, Kidney and liver transplantation patients experiencing GI AEs with current MMF treatment

Brief 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.

Interventions

DRUGEnteric-coated Mycophenolate sodium (EC-MPS)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
Gastro-intestinal adverse events before switch versus 3 months after switch	—

Secondary

Measure	Time frame
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	—

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026