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

January 28, 2011 updated by: Novartis

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure
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;

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

March 27, 2006

First Submitted That Met QC Criteria

March 27, 2006

First Posted (Estimate)

March 29, 2006

Study Record Updates

Last Update Posted (Estimate)

January 31, 2011

Last Update Submitted That Met QC Criteria

January 28, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CERL080A2405IT02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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