Efficacy and Tolerability of Full Dose Enteric-coated Mycophenolate Sodium, in Addition to Cyclosporine for Microemulsion Reduced Dose, in Maintenance Renal Transplant Recipients

Study Overview
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Brief Summary
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The study will evaluate kidney graft function in maintenance renal transplant patients.

Official Title
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Controlled, Randomized, Parallel Group Study to Assess Efficacy and Tolerability of Full Dose Enteric-coated Mycophenolate Sodium, in Addition to Cyclosporine for Microemulsion Reduced Dose, in Maintenance Renal Transplant Recipients

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: Enteric coated mycophenolate sodium (Myfortic®)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Male or female recipients of single or double renal transplant performed since at least one year and no more that 5 years Age > 18 yrs Adequate and stable renal function Informed consent. Exclusion criteria: Kidney transplant combined with other organs; Significant proteinuria Severe ongoing infections; Present or historical malignant neoplasia, of any type, with the exception of excised non metastatic non-melanoma skin cancer and previous malignant neoplasia cured since at least 5 years; Relapse of the end-stage renal disease on the transplanted kidney; Leucopenia, thrombocytopenia or severe anemia; 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

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full Dose Myfortic® and Reduced Dose Neoral®<br>The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME | Drug: Enteric coated mycophenolate sodium (Myfortic®)<br> <br> * Other names: Myfortic;|
| Active Comparator: Standard Dose of Myfortic® and Standard Dose of CsA-ME<br>Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME. | Drug: Enteric coated mycophenolate sodium (Myfortic®)<br> <br> * Other names: Myfortic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Function, as Assessed by Glomerular Filtration Rate (GFR) at 12 Months | The 12 month change from baseline (visit 2) in the glomerular filtration rate using the abbreviated Modification of Diet in Renal Disease (MDRD) formula to calculate GFR using the participant's serum creatinine, age, gender and ethnicity. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinine Clearance at 12 Months |  | 12 months | 
| Serum Creatinine at 12 Months |  | 12 months | 
| Reciprocal Slope of Serum Creatinine (mg/dL) or Micromole/l at 12 Months |  | 12 months | 
| Biopsy Proven Acute Rejections and Clinically Confirmed Acute Rejection at 12 Months |  | 12 months | 
| Chronic Rejection as Confirmed by Renal Biopsy at 12 Months |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Transplantation, Mycophenolic Acid, Immunosuppression, Cyclosporine