Clinical trial NCT00308425: Safety and Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) Plus Valsartan in Patients With Kidney Transplants (MYTHOS
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: De Novo Renal Transplantation
Keywords: Renal transplantation, EC-MPS
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-03-29
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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

Primary outcomes:
measure: 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 outcomes:
measure: Renal function, as measured by serum creatinine and calculated creatinine clearance after 6 and 12 months;
measure: Glomerular filtration rate (GFR), as plasma clearance of unlabeled iohexol, after 6 and 12 months;
measure: Albumin excretion rate and fractional clearance of albumin after 6 and 12 months;
measure: Fasting blood glucose levels, total cholesterol, triglyceride and HDL levels and systolic and diastolic blood pressure after 6 and 12 months;
measure: Incidence of acute rejection after 6 and 12 months;
measure: Patient and graft survival at 12 months;
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References: