Measurement of Patient Reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Renal Transplant Recipients (MyLife)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00149968

Enrollment

196

Registered

2005-09-08

Start date

2005-04-30

Completion date

2007-01-31

Last updated

2020-02-11

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

Conditions

Gastrointestinal Problems, Renal Transplantation

Keywords

Renal transplantation, MMF, EC-MPS, GI problems

Brief summary

The purpose of this study is to assess whether a switch from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI- and/or health-related quality of life outcomes, and to determine the proportion of renal transplant recipients who are experiencing any GI complaints under MMF-based immunosuppressive treatment.

Interventions

DRUGEnteric-Coated Mycophenolate Sodium (EC-MPS)

Patient on MMF treatment completes questionnaire and switch to equimolar doses of Myfortic. Maximum daily dose 1440 mg

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Received kidney transplant at least 3 months prior to study enrollment * Receiving immunosuppressive regimen that includes MMF in combination with other immunosuppressive drugs * Receiving MMF for at least 1 month prior to enrollment

Exclusion criteria

* Patients with any known hypersensitivity against mycophenolic acid, mycophenolate sodium, mycophenolate mofetil or other components of the formulations (e.g. lactose; see also summary of product characteristics of EC-MPS) * If applicable, GI symptoms assumed or known not to be caused by MPA therapy (e.g. oral biphosphonates induced, infectious diarrhea) * Acute rejection \< 1 week prior to study enrollment Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Changes in gastrointestinal symptom severity after conversion from MMF to enteric-coated mycophenolate sodium	week 0, week 6-8

Secondary

Measure	Time frame
Gastrointestinal symptoms under MMF-based immunosuppressive therapy	week 0, week 6-8
Assessment of quality of life, impact of immunosuppressive-induced gastrointestinal symptoms on patient's perception of symptom severity and quality of life	week 0, week 6-8

Countries

Germany, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026