- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00975663
Bayesian Dose Adjustment of Immunosuppressants After Lung Transplantation (BASALT)
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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Bruxelles, Belgique
- Service de Pneumologie
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Grenoble, France
- Pôle Médecine Aiguë et Communautaire, Clinique de Pneumologie,
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Lyon, France
- Service de Pneumologie, HCL Lyon
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Marseille, France
- ApHm -Chirurgie thoracique
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Nantes, France
- Service de Pneumologie-CHU de Nantes
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Paris, France
- Service de Chirurgie Cardiovasculaire - Hôpital Georges Pompidou
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Paris, France
- Service de Pneumologie - CH de Suresnes
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Paris, France
- Service de Pneumologie - Phtisiologie - Hôpital Bichat
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Strasbourg, France
- Service de Pneumologie - CHU de Strasbourg
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Immunosuppressive treatment failure
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Efficacy score
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Pierre MARQUET, MD, CHU Limoges
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- I07038
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