MYPROMS-ES02: Safety and Efficacy of Basiliximab, Cyclosporine Microemulsion and Enteric-coated Mycophenolate Sodium (EC-MPS) Versus EC-MPS and Steroid Therapy in Kidney Transplant Recipients Who Are Hepatitis C Positive

Study Overview
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Brief Summary
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To prospectively evaluate in de novo kidney transplant recipients, hepatitis C positive, the clinical outcomes of an immunosuppressive regimen of EC-MPS free of steroids in comparison with a regimen of EC-MPS with standard steroids, as measured by the hepatic function tests (ALT/AST) after 12 months treatment.

Official Title
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A Twelve-month, Randomized, Multicenter, Open-label, Exploratory Study to Investigate the Clinical Outcomes of an Immunosuppressive Regimen of Basiliximab, Cyclosporine Microemulsion (CsA-ME) and Enteric-coated Mycophenolate Sodium (EC-MPS) Free of Steroids Compared With a Regimen of EC-MPS With Standard Steroids in de Novo Kidney Recipients Who Are Hepatitis C Positive

Conditions
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De Novo Kidney Transplant

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 Patients hepatitis C positive (serology test within the last 12 months and determined by third-generation assay). Recipients of heart-beating cadaveric, living unrelated or living related non-HLA identical donor kidney transplant, treated with basiliximab and CsA-ME as primary immunosuppression. Exclusion criteria Multi-organ recipients (e.g. double kidney, kidney and pancreas or kidney and liver) or previous transplant with any other organ. Kidneys from non-heart beating donors. ABO incompatibility against the donor. Patients with panel reactive antibodies of >50% at most recent assessment prior to transplantation and /or prior graft lost due to immunological reasons in the first six months post-transplantation or patients who are considered to be at increased risk of acute rejection by the principal investigator Additional protocol defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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

| 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 |
| --- | --- | --- |
| Hepatic function tests (ALT/AST) after 12 months treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acumulative incidence of biopsy proven acute rejection after 3 and 12 months. |  |  | 
| Graft loss, biopsy-proven acute rejection after 3 and 12 months treatment. |  |  | 
| Glomerular filtration rate and by proteinuria after 12 months treatment. |  |  | 
| Graft survival after 12 months. |  |  | 
| Incidence of AEs and SAEs after 3 and 12 months. |  |  | 
| Blood pressure, lipids and glucose profiles after 3 and 12 months. |  |  | 
| Percentage of patients free of steroids at 12 months between the two investigational groups. |  |  | 
| Viral load (HCV RNA) between both groups at 12 months. |  |  | 
| Bone density at 12 months in both groups. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney transplant, hepatitis C, enteric-coated mycophenolate sodium