Bayesian Dose Adjustment of Immunosuppressants After Lung Transplantation (BASALT)
23. april 2011 oppdatert 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.
Studieoversikt
Status
Avsluttet
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Forventet)
180
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Bruxelles, Belgia
- 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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Immunosuppressive treatment failure
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Efficacy score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Pierre MARQUET, MD, CHU Limoges
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2009
Primær fullføring (Faktiske)
1. februar 2011
Studiet fullført (Faktiske)
1. februar 2011
Datoer for studieregistrering
Først innsendt
10. september 2009
Først innsendt som oppfylte QC-kriteriene
10. september 2009
Først lagt ut (Anslag)
11. september 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
26. april 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. april 2011
Sist bekreftet
1. april 2011
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- I07038
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