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

Novartis

Status and phase: Completed; Phase 3

Conditions: De Novo Renal Transplantation

Treatments: Drug: Enteric-coated Mycophenolate sodium (EC-MPS), valsartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00308425

CERL080A2405IT02

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

2. Multi-organ recipients (e.g. kidney and pancreas, double kidney) or previous transplant with any other organ.

3. 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

4. Recipient who is HLA-identical to the donor

5. Patients with a PRA level (past or current level) higher than 50%

6. Patients with a known hypersensitivity to EC-MPS or other components of the formulation (e.g. lactose).

7. 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.

8. HIV-positive

9. Positive HBsAg test for both donor and recipients.

10. 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

11. Liver injury as indicated by transaminase serum levels (ALT and/or AST) greater than 2 x ULN

12. Creatinine kinase (CK) levels greater than 5 x ULN. Additional protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)