Safety and Tolerability of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients With GI Intolerance

Study Overview
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Brief Summary
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The aim of this study is to evaluate the safety and tolerability of EC-MPS in maintenance renal transplant patients who experience gastrointestinal (GI) intolerance due to adverse events associated with mycophenolate mofetil (MMF) and were converted to EC-MPS.

Official Title
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Safety and Tolerability of Enteric-Coated Mycophenolate Sodium in Renal Transplant Patients With GI Intolerance

Conditions
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Renal Transplantation

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: Males and females aged 18-75 years. Recipients of first or secondary cadaveric, living unrelated or living related kidney transplant. Recipients who are at least 4 weeks post renal transplantation. Patients currently receiving MMF (all dosages are allowed), cyclosporine microemulsion, its generic equivalent, cyclosporine USP (modified) or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 2 weeks. Patients with mild and/or moderate GI complaints (e.g. upper abdominal pain, dyspepsia, anorexia, nausea, vomiting) with or without diarrhea. Exclusion Criteria: Multi-organ patients (e.g. kidney and pancreas) or previous transplant with any other organ different from kidney (secondary kidney transplant is allowed). Evidence of graft rejection, treatment of acute rejection or unstable renal function within 4 weeks prior to baseline visit. Patients who have received an investigational immunosuppressive drug within 4 weeks prior to study entry. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enteric-coated mycophenolate sodium (EC-MPS)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of EC-MPS in combination with CsA-ME or tacrolimus as determined by gastrointestinal symptom rating scale (GSRS) after conversion from MMF in maintenance renal transplant patients with GI intolerance |  | within 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of EC-MPS in combination with CsA-ME or tacrolimus as determined by incidence and severity of GI adverse events |  | within 3 months | 
| Tolerability of EC-MPS in combination with CsA-ME or tacrolimus as determined by gastrointestinal symptom rating scale (GSRS) |  | within 1 month | 
| Efficacy of EC-MPS in combination with CsA-ME or tacrolimus as measured by the incidence of biopsy-proven acute rejection |  | within 3 months | 
| Tolerability of EC-MPS in combination with CsA-ME or tacrolimus by comparing the two study groups |  | after 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal/Kidney, Transplantation, MPA, EC-MPS, Renal Transplantation Patients with GI Intolerance with MMF