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Bayesian Dose Adjustment of Immunosuppressants After Lung Transplantation

NCT00975663 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2011-04-26

No results posted yet for this study

Summary

The purpose of this study is to evaluate in lung or heart-lung transplant patients on tacrolimus and mycophenolate the impact of optimized mofetil (MMF) therapeutic drug monitoring and dose adjustment of both drugs on the incidence of treatment failure over the first three years post-transplantation.

Conditions

  • Lung and Heart-lung Transplantation

Interventions

DRUG

Tacrolimus and MMF

Tacrolimus: daily oral dose divided into 2 doses (morning and evening). MMF: daily dose divided into 2 doses at 12 hour intervals or 3 doses at 8 hour intervals.

DRUG

Tacrolimus and MMF

Tacrolimus: daily oral dose divided into 2 doses (morning and evening). MMF: daily dose divided into 2 doses at 12 hour intervals or 3 doses at 8 hour intervals.

Sponsors & Collaborators

  • University Hospital, Limoges

    lead OTHER

Principal Investigators

  • Pierre MARQUET, MD · CHU Limoges

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • Belgium
  • France

Study Locations

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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 NCT00975663 on ClinicalTrials.gov