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

Study Overview
=================
Brief Summary
-----------------
This trial is designed to assess the efficacy, tolerability, and safety of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in kidney transplant recipients.

Official Title
-----------------
A Prospective, Open Label, Multicenter Study to Assess the Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients

Conditions
-----------------
De Novo Kidney Transplant Recipients

Intervention / Treatment
-----------------
* Drug: Enteric-coated Mycophenolate sodium (EC-MPS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Males and females aged 18 to 75 years. Recipients of living related kidney transplant, treated with cyclosporine, with or without corticosteroids, as primary immunosuppression. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to or at screening. Effective contraception must be used during the trial, and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility. Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained. 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 other components of the formulation (e.g. lactose). Patients with low platelet count (< 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 who have received an investigational drug within four weeks prior to study entry. Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception. Additional protocol-defined inclusion/exclusion criteria may apply

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

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

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?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient and graft survival |  |  | 
| acute rejection incidence |  |  | 
| graft function at 6 months post transplant. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| influence of age, gender, and post-transplantation complications on the main clinical outcomes |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
De novo Kidney Transplant recipients, enteric-coated mycophenolate sodium