A Study to Investigate the Tolerability and Safety of Converting Stable Renal Transplant Recipients Who Receive Tacrolimus With or Without Corticosteroids From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)

Study Overview
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Brief Summary
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The aim of this study is whether a switch of stable renal transplant recipients who receive tacrolimus with or without corticosteroids from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) is safe and well tolerated by the patients.

Official Title
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A 6-month, 1-arm, Open-label Study to Investigate the Tolerability and Safety of Converting Stable Renal Transplant Recipients Who Receive Tacrolimus With or Without Corticosteroids From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)

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: Recipients of first or secondary cadaveric heart-beating, living unrelated or living related kidney transplant. Currently receiving 1, 1.5, or 2 g MMF/day, tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 3 months. In a stable condition in terms of graft function. Exclusion criteria: Patients who had taken an investigational drug within four weeks prior to study entry History of malignancy within the last 5 years, except excised squamous or basal cell carcinoma of the skin. Thrombocytopenia (<75,000/mm3), with an absolute neutrophil count of <1,500/mm3 and/or leukocytopenia (<2,500/mm3), and/or hemoglobin <6.0 g/dL prior to enrollment Clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus, evidence of severe liver disease, HIV or Hepatitis B surface antigen positive. 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: Single Group 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 based on adverse events within 6 months after switch from MMF to an optimized enteric-coated mycophenolate sodium regimen. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety based on renal function within 6 months after medication switch. |  |  | 
| Pharmacokinetics of enteric-coated mycophenolate sodium in combination with tacrolimus in a subpopulation at baseline, week 2, month 3 |  |  | 
| Influence of enteric-coated mycophenolate sodium on the activity of an enzyme at baseline, week 2, month 3 |  |  | 
| Incidence of biopsy-proven acute rejection, graft loss or death within 6 months post medication switch. |  |  | 
| Graft survival and patient survival 6 months post medication switch. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal transplantation, Enteric-coated mycophenolate sodium