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

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3

Details

• Lead Sponsor: Novartis
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Valsartan

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

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

2. 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

3. Recipient who is HLA-identical to the donor

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

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

6. 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.

7. HIV-positive

8. Positive HBsAg test for both donor and recipients.

9. 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

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

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