Bayesian Dose Adjustment of Immunosuppressants After Lung Transplantation (BASALT)
23 april 2011 uppdaterad av: University Hospital, Limoges
Evaluation of the Interest of Therapeutic Drug Monitoring of Immunosuppressants (Tacrolimus, Mycophenolate Mofetil) Based on Bayesian Estimation During the Three First Years Following Lung Transplantation, in Patients With or Without Cystic Fibrosis
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This research will be based on a prospective randomized trial comparing optimized TDM of tacrolimus and MMF to the current strategy of tacrolimus and MMF dose adjustment in lung transplant recipients. The study will focus on the first three years post-transplantation, as treatment failures (including BOS) occur mainly during this post-transplantation period. As the aim of tacrolimus and MMF dose individualization is to avoid over- or underexposure, for the purpose of this study treatment failure will be a composite criterion gathering events which reflect both over- and underexposure to tacrolimus and MMF.
Optimized TDM of tacrolimus and MMF based on blood tacrolimus and plasma MPA AUC Bayesian estimation will be compared to current strategies: tacrolimus dose adjustment based on trough levels (C0) and administration of a standard dose of MMF, decreased by the pulmonologist in case of adverse drug reactions or increased in case of inefficacy. The efficacy of optimized strategy vs. current strategies will be mainly evaluated through the incidence of treatment failure.
Studietyp
Interventionell
Inskrivning (Förväntat)
180
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Bruxelles, Belgien
- Service de pneumologie
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Grenoble, Frankrike
- Pôle Médecine Aiguë et Communautaire, Clinique de Pneumologie,
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Lyon, Frankrike
- Service de Pneumologie, HCL Lyon
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Marseille, Frankrike
- ApHm -Chirurgie thoracique
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Nantes, Frankrike
- Service de Pneumologie-CHU de Nantes
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Paris, Frankrike
- Service de Chirurgie Cardiovasculaire - Hôpital Georges Pompidou
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Paris, Frankrike
- Service de Pneumologie - CH de Suresnes
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Paris, Frankrike
- Service de Pneumologie - Phtisiologie - Hôpital Bichat
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Strasbourg, Frankrike
- Service de Pneumologie - CHU de Strasbourg
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria
- 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 on oral tacrolimus and MMF for at least 48 hours at the time of inclusion (administration via a naso-gastric tube possible if necessary)
- 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
Exclusion Criteria:
- 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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 1
Optimized TDM of tacrolimus and MMF dosing
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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.
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Aktiv komparator: 2
Current tacrolimus and MMF dosing strategies
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Immunosuppressive treatment failure
Tidsram: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Efficacy score
Tidsram: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Toxicity score
Tidsram: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Benefit/risk ratio
Tidsram: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Each event composing the composite criterion
Tidsram: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Overall cost of patients monitoring
Tidsram: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Pharmacogenetic and proteomic analysis
Tidsram: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Pierre MARQUET, MD, CHU Limoges
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2009
Primärt slutförande (Faktisk)
1 februari 2011
Avslutad studie (Faktisk)
1 februari 2011
Studieregistreringsdatum
Först inskickad
10 september 2009
Först inskickad som uppfyllde QC-kriterierna
10 september 2009
Första postat (Uppskatta)
11 september 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
26 april 2011
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 april 2011
Senast verifierad
1 april 2011
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- I07038
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