Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients

Study Overview
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Brief Summary
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The aim of MYFORMS is to assess efficacy and safety on clinical outcomes of EC-MPS in combination with Cyclosporine microemulsion (CsA-ME) in kidney transplant recipients.

Official Title
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Phase IV Study of Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion (CsA-ME) in Kidney Transplant Patients

Conditions
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Kidney 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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De Novo-Inclusion criteria Males and females aged 6 years or over. Recipients of cadaveric, living unrelated or living related kidney transplant, treated with CsA-Me, with or without corticosteroids, as primary immunosuppression. Maintenance-Inclusion criteria Males and females aged 6 years or over. Recipients of first or secondary cadaveric, living related or unrelated donor kidney transplant. Patients currently receiving CsA-ME with or without Mycophenolate mofetil (MMF) or azathioprine, with or without corticosteroids as part of their immunosuppressive regimen for at least 3 months prior to Screening. Patients in a stable condition in terms of graft function (serum creatinine not above 2.3 mg/dL (=204 µmol/L) at screening and at baseline, or not increased by more than 20% at baseline compared to values obtained at screening), no change of immune suppressive regimen due to graft malfunction, and any known clinically significant physical and/or laboratory changes for at least 2 months prior to enrollment. De Novo and Maintenance-Exclusion Criteria Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney. Patients with any known hypersensitivity to MPA, EC-MPS or other components of the formulation (e.g. lactose). Patients with thrombocytopenia (< 75,000/mm3), with an absolute neutrophil count of < 1,500/mm3, and/or leukocytopenia (< 2,500/mm3), and/or hemoglobin < 6 g/dL at Screening or Baseline. Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 6 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: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EC-MPS<br> | Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient and graft survival |  |  | 
| acute rejection incidence |  |  | 
| graft function |  |  | 
| safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| influence of demographic characteristics, transplant-related variables, medical conditions and post-transplantation complications on the main clinical outcomes, according to the immunosuppressive regimen used. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MYFORMS, Kidney Transplantation, Enteric-Coated Mycophenolate Sodium (EC-MPS), Cyclosporine microemulsion (CsA-ME)