Gastrointestinal and Health-related Quality of Life in Kidney Transplant Patients Treated With Mycophenolate Mofetil

A 12-week Multicenter, Randomized, Open Study to Evaluate the Effects of Enteric-coated Mycophenolate Sodium (EC-MPS) in Terms of Quality of Life in Patients With Gastrointestinal (GI) Symptoms Treated With MMF (Mycophenolate Mofetil) After Kidney Transplant.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00400647

Enrollment

136

Registered

2006-11-17

Start date

2006-07-31

Completion date

2008-09-30

Last updated

2017-02-07

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

Conditions

Maintenance Kidney Transplant

Keywords

kidney transplant, enteric-coated mycophenolate sodium, quality of life, gastrointestinal symptoms

Brief summary

This study will assess the quality of life in renal transplant recipients who require a reduced dose of mycophenolate mofetil (MMF) because of gastrointestinal (GI) side effects and will also access the relationship between mycophenolic acid (MPA) dose in those patients receiving enteric-coated mycophenolate sodium formulation(EC-MPS). Patients will be evaluated at baseline, 2 weeks after study medicine conversion and then again at 12 weeks post-conversion.

Interventions

DRUGEnteric-coated Mycophenolate sodium (EC-MPS)

DRUGMycophenolate mofetil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Patients who are recipients of a renal transplant. 2. Patients treated with an immunosuppressive regiment including MMF before recruitment. 3. Patients suffering from GI side effects related to MMF standard doses or patients treated with a reduced MMF dose to control the aforementioned GI side effects. 4. Patients 18 years or older. 5. Patients who have given written informed consent to participate in the study 6. Patients complying with all study requirements including completing questionnaires and attending to the three study visits.

Exclusion criteria

1. Patients with GI symptoms assumed or known not to be caused by MPA therapy (eg. oral bisphosphonate induced, infectious diarrhea) 2. Acute rejection less than 1 week before recruitment. 3. Females of childbearing potential who are pregnant, planning to get pregnant and/or breast feeding or not willing to practice an approved method of birth control. 4. Presence of psychiatric disorder, such as schizophrenia or major depression, in the investigator's opinion, could interfere with study requirements. 5. Patients undergoing surgery due to acute illness or hospitalized. 6. Existence of any medical condition which, in the investigator's opinion based on anamnesis or medical records, could affect study completion, including but not limiting visual problems or cognitive deterioration. 7. Patients currently treated or who have been treated with any other study drug or treatment within 30 days prior to baseline visit. Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
To determine the effect of the use of EC-MPS on the quality of life of patients requiring MMF dose reduction due to gastrointestinal symptoms	12 weeks

Secondary

Measure	Time frame
To determine whether EC-MPS enables the administration of higher doses with good tolerability, compared with standard MMF treatment, in patients with shown susceptibility to undesirable GI effects	12 weeks
To measure health-related quality of life (HRQOL) through the GI quality of life index (GIQLI) and the psychological general well-being index (PGWB)	12 weeks

Countries

Switzerland

Outcome results

None listed

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