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

Study Overview
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Brief Summary
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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.

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

Conditions
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Renal Transplantation, Gastrointestinal Problems

Intervention / Treatment
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* Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)


Participation Criteria
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Eligibility Criteria
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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/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myfortic<br> | Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)<br>* Patient on MMF treatment completes questionnaire and switch to equimolar doses of Myfortic. Maximum daily dose 1440 mg<br>* Other names: Myfortic;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal transplantation, MMF, EC-MPS, GI problems