Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients

Study Overview
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Brief Summary
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This study will investigate the safety, tolerability and efficacy of EC-MPS with tacrolimus at both reference and reduced levels. This study will take into account safety aspects such as decreased renal toxicity by reducing the overall exposure to tacrolimus.

Official Title
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A Six-month, Prospective, Multicenter, Open Label, Parallel, Randomized Study of the Safety, Tolerability and Efficacy of EC-MPS With Basiliximab, Corticosteroids and Two Different Levels of Tacrolimus in de Novo Renal Transplant Recipients

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: EC-MPS, Tacrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female kidney transplantation patients, 18 to 70 years of age, receiving a primary cadaveric, living unrelated, or non-HLA identical living related donor kidney. The renal cold ischemic time (CIT) must be <30 hours The age of the donor must be between 10 and 65 years Exclusion Criteria Patients who have previously received an organ transplant Patients who are recipients of a multiple organ transplants Recipients of non heart-beating donor organs ABO incompatibility against the donor Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: reduced Tacrolimus<br> | Drug: EC-MPS, Tacrolimus<br> <br> |
| Active Comparator: Reference Tacrolimus<br> | Drug: EC-MPS, Tacrolimus<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function at 6 months posttransplant as measured by glomerular filtration rate |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy as measured by combined incidence of biopsy proven acute rejection episodes, graft loss, and death at 6 months |  |  | 
| Renal function as measured by calculated creatinine clearance |  |  | 
| Cockcroft-Gaultand serum creatinine at 6 months |  |  | 
| Gastrointestinal tolerability as measured by gastrointestinal |  |  | 
| symptom rating scale (GSRS) at various time points |  |  | 
| Safety as measured by incidence of adverse events |  |  | 
| Effects on glucose metabolism at months 3 and 6 after transplantation. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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De novo kidney recipients,, EC-MPS,, tacrolimus,, efficacy,, safety,, glomerular filtration rate, Treatment in de novo kidney recipients