Safety and Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) Plus Valsartan in Patients With Kidney Transplants (MYTHOS

Study Overview
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Brief Summary
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The primary aim of this study is to evaluate the safety and efficacy of EC-MPS plus valsartan as part of an intensified multifactorial intervention on the reduction of the 12-month rate of transplant nephropathy compared with EC-MPS plus standard practice of care in recipients of a first cadaver donor kidney transplant given CsA-ME, basiliximab, and short-term steroids.

Official Title
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Effect of Enteric-Coated Mycophenolate Sodium (EC-MPS) Plus Valsartan as Part of Intensified Multi-factorial Intervention Compared to EC-MPS Plus Standard Practice of Care on Development of Transplant Nephropathy in Cadaver Donor Kidney Recipients Given Basiliximab, Cyclosporine Microemulsion (CsA-ME) and Short-term Steroids: a 12-month, Prospective, Randomized, Open-label Multicentre Study (MYTHOS)

Conditions
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De Novo Renal Transplantation

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


Participation Criteria
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Eligibility Criteria
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Inclusion criteria 1. Male and female patients aged 18 to 70 years 2. Patients receiving a first kidney transplant from a cadaver donor, who are scheduled to receive CsA-ME and anti-CD25 antibody as primary immunosuppression; 3. Patients able to receive the first dose of EC-MPS within 48 hours of graft reperfusion Exclusion criteria Multi-organ recipients (e.g. kidney and pancreas, double kidney) or previous transplant with any other organ. Recipient of a kidney from a non-heart beating, from a cadaver donor aged more than 70 years, or with cold ischemia time of more than 36 hours Recipient who is HLA-identical to the donor Patients with a PRA level (past or current level) higher than 50% Patients with a known hypersensitivity to 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. HIV-positive Positive HBsAg test for both donor and recipients. Unstable angina, acute myocardial infarction or stroke during the last 6 month or heart failure NYHA class III-IV or hemodinamically significant valvular heart disease Liver injury as indicated by transaminase serum levels (ALT and/or AST) greater than 2 x ULN Creatinine kinase (CK) levels greater than 5 x ULN. Additional protocol-defined inclusion/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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enteric-coated Mycophenolate sodium (EC-MPS), valsartan|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-month rate of success in preventing relapse of nephropathy, defined as persistent albumin excretion rate (AER) > 300 mg/24h and safety, compared between groups. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function, as measured by serum creatinine and calculated creatinine clearance after 6 and 12 months; |  |  | 
| Glomerular filtration rate (GFR), as plasma clearance of unlabeled iohexol, after 6 and 12 months; |  |  | 
| Albumin excretion rate and fractional clearance of albumin after 6 and 12 months; |  |  | 
| Fasting blood glucose levels, total cholesterol, triglyceride and HDL levels and systolic and diastolic blood pressure after 6 and 12 months; |  |  | 
| Incidence of acute rejection after 6 and 12 months; |  |  | 
| Patient and graft survival at 12 months; |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal transplantation, EC-MPS