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

De Novo Renal Transplantation Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00308425
• Other study ID #: CERL080A2405IT02
• Status: Completed
• Phase: Phase 3
• First received: March 27, 2006
• Last updated: January 28, 2011
• Start date: October 2002
• Est. completion date: June 2005

Study information

• Verified date: January 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• De Novo Renal Transplantation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Outcome

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