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Evaluation of the Therapeutic Benefit of an Initial Intensified Dosing Regimen of Mycophenolate Sodium Versus a Standard Regimen in Renal Transplant Patients

NCT00419926 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 313

Last updated 2011-03-01

Study results available
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Summary

The purpose of this study is to determine if an initial intensified enteric-coated mycophenolate sodium (Myfortic) dosing regimen administered during the first six weeks post renal transplantation provides improved efficacy, with a similar safety profile, compared to a standard regimen of Myfortic.

Conditions

  • Kidney Transplantation

Interventions

DRUG

Enteric-coated mycophenolate sodium (Myfortic)

1440 mg/day for the standard dose. 2880 mg/day for the initial intensified dosage, reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.

DRUG

Cyclosporine (Neoral)

cyclosporine microemulsion in galenic form capsules starting at twice a day for a dose of 8-10 mg/kg/day adjusted if necessary to achieve protocol specific target levels

DRUG

Prednisone

20 mg orally per day reduced according to center practice for a minimum dose of 5 mg/day.

Sponsors & Collaborators

Principal Investigators

  • Novartis · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • Switzerland

Study Locations

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Drugs
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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 NCT00419926 on ClinicalTrials.gov