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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: March 27, 2006
Last updated: January 28, 2011
Last verified: January 2011

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.

Condition Intervention Phase
De Novo Renal Transplantation
Drug: Enteric-coated Mycophenolate sodium (EC-MPS), valsartan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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)

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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:
  • 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;

Enrollment: 119
Study Start Date: October 2002
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00308425

Sponsors and Collaborators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Identifier: NCT00308425     History of Changes
Other Study ID Numbers: CERL080A2405IT02
Study First Received: March 27, 2006
Last Updated: January 28, 2011
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Novartis:
Renal transplantation, EC-MPS

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents processed this record on April 15, 2014