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Cardiovascular Risk Following Conversion to Full Dose Myfortic® and Neoral® Two-hour Post Level Monitoring

NCT02058875 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2017-01-09

No results posted yet for this study

Summary

The overall goal of this study is to improve cardiovascular outcomes in transplant recipients. The current standard immunosuppressive regimen in kidney transplant recipients depends on a higher exposure to the Calcineurin Inhibitor (CNI), and often a less than optimal dosage the of mycophenolic acid (MPA) derivative. The premise of this study is to investigate the effects of reversing this paradigm. More specifically, the effect of using maximum MPA dosages (in the form of enteric-coated mycophenolate sodium \[EC-MPS\] or Myfortic®) along with judicious CNI exposure (cyclosporine/Neoral®) will be investigated.

Conditions

Interventions

DRUG

Myfortic®

DRUG

Neoral®

DRUG

Cellcept®

DRUG

Prednisone

Sponsors & Collaborators

  • University of Saskatchewan

    lead OTHER

Principal Investigators

  • Ahmed Shoker, MD · University of Saskatchewan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02058875 on ClinicalTrials.gov