NCT00975663

Brief 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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2009

Geographic Reach
2 countries

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

April 26, 2011

Status Verified

April 1, 2011

Enrollment Period

1.4 years

First QC Date

September 10, 2009

Last Update Submit

April 23, 2011

Conditions

Lung and Heart-lung Transplantation

Keywords

Lung transplantationheart-lung transplantationtherapeutic drug monitoringtacrolimusmycophenolateimmunosuppressantpharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Immunosuppressive treatment failure

    Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation

Secondary Outcomes (6)

  • Efficacy score

    Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation

  • Toxicity score

    Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation

  • Benefit/risk ratio

    Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation

  • Each event composing the composite criterion

    Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation

  • Overall cost of patients monitoring

    Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Optimized TDM of tacrolimus and MMF dosing

Drug: Tacrolimus and MMF

2

ACTIVE COMPARATOR

Current tacrolimus and MMF dosing strategies

Drug: Tacrolimus and MMF

Interventions

Tacrolimus and MMFDRUG

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.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients aged 18 years or more
  • CF and non-CF patients receiving single-lung or double-lung or heart-lung transplantation for the first time
  • Patients without progressive chronic pathology jeopardizing short term patient and graft survival
  • Patients accepting to comply with at least the evaluation visits planned in the investigation center over the first three years post-transplantation (D7, D14, M1, M3, M6, M12, M18, M24, M30, M36)
  • Patients giving their free and informed written consent to participate in this study
  • Patients with a health insurance policy or registered under a health insurance program

You may not qualify if:

  • Patients aged less than 18 years or patients over 18 years under guardianship
  • Patients who disagree with this research
  • Patients with a contra-indication to receiving tacrolimus or MMF
  • Patients on cyclosporine, sirolimus or everolimus
  • Patients who have already benefited from a solid organ transplantation in the past (including lung or heart-lung transplantation)
  • Patients infected by Burkholderia cenocepacia (Burkholderia cepacia genomovar III)
  • Patients receiving HIV protease inhibitors (major pharmacokinetic interaction with tacrolimus)
  • Pregnant or breastfeeding women or those of child-bearing age who do not use an efficient contraceptive method
  • Drug users or patients suffering from neuro-psychiatric disorders preventing them from both proper comprehension of the protocol and reliable consent
  • Patients already participating in another interventional clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Service de Pneumologie

Brussels, Belgium

Location

Pôle Médecine Aiguë et Communautaire, Clinique de Pneumologie,

Grenoble, France

Location

Service de Pneumologie, HCL Lyon

Lyon, France

Location

ApHm -Chirurgie thoracique

Marseille, France

Location

Service de Pneumologie-CHU de Nantes

Nantes, France

Location

Service de Chirurgie Cardiovasculaire - Hôpital Georges Pompidou

Paris, France

Location

Service de Pneumologie - CH de Suresnes

Paris, France

Location

Service de Pneumologie - Phtisiologie - Hôpital Bichat

Paris, France

Location

Service de Pneumologie - CHU de Strasbourg

Strasbourg, France

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Pierre MARQUET, MD

    CHU Limoges

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2009

First Posted

September 11, 2009

Study Start

September 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

April 26, 2011

Record last verified: 2011-04

Locations

BE(1)FR(8)