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Completed

NCT Number: NCT00308425

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

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.

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Key information

Conditions

De Novo Renal Transplantation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Multi-organ recipients (e.g. kidney and pancreas, double kidney) or previous transplant with any other organ.
  • 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
  • Recipient who is HLA-identical to the donor
  • Patients with a PRA level (past or current level) higher than 50%
  • Patients with a known hypersensitivity to EC-MPS or other components of the formulation (e.g. lactose).
  • 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.
  • HIV-positive
  • Positive HBsAg test for both donor and recipients.
  • 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
  • Liver injury as indicated by transaminase serum levels (ALT and/or AST) greater than 2 x ULN
  • Creatinine kinase (CK) levels greater than 5 x ULN. Additional protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Enteric-coated Mycophenolate sodium (EC-MPS), valsartan

Drug

Primary outcomes

  1. 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

  1. Renal function, as measured by serum creatinine and calculated creatinine clearance after 6 and 12 months;

  2. Glomerular filtration rate (GFR), as plasma clearance of unlabeled iohexol, after 6 and 12 months;

  3. Albumin excretion rate and fractional clearance of albumin after 6 and 12 months;

  4. Fasting blood glucose levels, total cholesterol, triglyceride and HDL levels and systolic and diastolic blood pressure after 6 and 12 months;

  5. Incidence of acute rejection after 6 and 12 months;

  6. Patient and graft survival at 12 months;

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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)

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Mar 29, 2006
Registry last updated
Jan 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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