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Mycophenolate Mofetil for Reducing Cardiovascular Risk in Renal Transplant Recipients

NCT01213394 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2012-04-19

No results posted yet for this study

Summary

The purpose of this research study is to determine if adding or increasing the dose of CellCept while lowering the dose of tacrolimus (Prograf or Advagraf) or cyclosporine (Neoral), and/or steroids can reduce the likelihood of developing coronary heart disease in the next 10 years.

The investigators will calculate the change in risk of developing coronary heart disease using the Framingham score. The Framingham score is a mathematical equation that includes the following information: Age, Gender, Diabetes status, Smoking status, Lipids, Blood Pressure. The Framingham score estimates how likely it is that someone will develop coronary heart disease over the next 10 years.

Conditions

Interventions

DRUG

mycophenolate mofetil

Introduction of CellCept or increase in the dose of CellCept to a maximum of 2 g/day. In patients not already receiving CellCept, azathioprine (AZA), enteric-coated mycophenolate sodium (EC-MPS) or sirolimus (SRL) will be discontinued and replaced by CellCept in divided doses to a maximum of 2 g/day. CNI doses will be reduced to conform to the target trough levels in the low-dose CNI arms of the ELITE-Symphony study +/- steroid dose reduction. Any CNI dose change will require measurement of CNI trough levels at 7 days post dose change +/- 3 days. Target CNI trough levels in the Symphony study: * Low-dose CsA: Initial oral dose of 1-2 mg/kg bid, to achieve a target trough level of 50-100 ng/mL. * Low-dose TAC: Initial oral dose of 0.1 mg/kg/day divided into two doses\* with a target trough level of 3-7 ng/mL (\*Advagraf may also be used at a dose of 0.1 mg/kg once daily with a target trough level of 3-7 ng/mL)

OTHER

standard immunosuppression

Current immunosuppressive therapy will be maintained throughout the study unless a change is required for safety reasons.

Sponsors & Collaborators

Principal Investigators

  • Dr. Ramesh Prasad, MBBS MSc · Unity Health Toronto

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-10-31
Completion
2011-12-31

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01213394 on ClinicalTrials.gov