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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00308425
First Posted: March 29, 2006
Last Update Posted: January 31, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  Purpose
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
Intervention Model: Parallel Assignment
Masking: None (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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00308425


Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00308425     History of Changes
Other Study ID Numbers: CERL080A2405IT02
First Submitted: March 27, 2006
First Posted: March 29, 2006
Last Update Posted: January 31, 2011
Last Verified: January 2011

Keywords provided by Novartis:
Renal transplantation, EC-MPS

Additional relevant MeSH terms:
Mycophenolic Acid
Valsartan
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists