Informations générales (source: ClinicalTrials.gov)
Pharmacokinetic Assessment of Tacrolimus Exposure Before and After a Switch From Twice Daily Immediate-release (Prograf®) to Once-daily Prolonged Release Tacrolimus (Envarsus®) (ENVARSWITCH)
Interventional
Phase 4
University Hospital, Limoges (Voir sur ClinicalTrials)
octobre 2016
décembre 2020
29 juin 2024
Tools have been developed in our unit to calculate the inter-dose AUC (Area Under Curve)
of immunosuppressive drugs (ISD) based on a limited number of blood concentrations (i.e.,
blood samples) using Bayesian methods. Since 2005, we have implemented these tools in an
expert system and made them available to the transplant community through our very
successful ISBA (Immunosuppressive drugs Bayesian dose Adjustment) website.
Briefly, we first need to develop a population pharmacokinetic model using rich
pharmacokinetic (PK) profiles (about 10 samples per patient over the dosing interval).
The model developed can then be used for inference of ISD PK parameters in new patients
using Bayesian estimation. Bayes' theorem is based on conditional probability: individual
PK parameters are estimated based on the known PK parameters in the population (mean and
distribution), given the dose and concentrations observed in a patient. Our previous
studies have shown that a limited sampling strategy (LSS) based on 3 samples collected
within the first 3 hours after drug intake can estimate adequately the interdose AUC of
ISD. In the present study, the AUC0-24h and the recommended dose will be calculated using
Bayesian estimators previously developed using PK data from the clinical trials run by
Veloxis, and proposed to the clinicians via a dedicated website comparable with ISBA.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| IFSI AP-HP DE L'HÔPITAL TENON | Dany ANGLICHEAU, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Limoges Hospital - 87 042 - Limoges - France | Pierre MARQUET, MD | Contact (sur clinicalTrials) | |||
| University Hospital of Amiens - Amiens - France | Gabriel CHOUKROUN, MD | Contact (sur clinicalTrials) | |||
| University Hospital of Lille - Lille - France | Sébastien DHARANCY, MD | Contact (sur clinicalTrials) | |||
| University Hospital of Poitiers - Poitiers - France | Antoine THIERRY, MD | Contact (sur clinicalTrials) | |||
| University Hospital of Reims - Reims - France | Charlotte COLOSIO, MD | Contact (sur clinicalTrials) | |||
| University Hospital of Rouen - Rouen - France | Isabelle ETIENNE, MD | Contact (sur clinicalTrials) | |||
| University Hospital of Tours - Tours - France | Matthias BÜCHLER, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| University Hospital of Bordeaux - Bordeaux - France | Pierre MERVILLE, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. Adult (≥ 18 year-old) male and female patients
2. Recipient of a single kidney or liver allograft
3. Patient transplanted for more than 2 weeks and less than 1 year at enrolment
4. Patient with stable Prograf® dose, defined by the following criteria:
- Criterion 1: unchanged Prograf® dose for at least one week; if not, apply
criterion #2
- Criterion 2: unchanged Prograf® dose since the last two therapeutic drug
monitorings (TDM)
5. Patient for whom the decision is made to switch from Prograf® to Envarsus®
6. Written informed consent obtained prior to any study-related procedure
7. Patient with tacrolimus C0 between 4 and 12 µg/L at V1
8. Patient with hematocrit > 27% at V1
1. Adult (≥ 18 year-old) male and female patients
2. Recipient of a single kidney or liver allograft
3. Patient transplanted for more than 2 weeks and less than 1 year at enrolment
4. Patient with stable Prograf® dose, defined by the following criteria:
- Criterion 1: unchanged Prograf® dose for at least one week; if not, apply
criterion #2
- Criterion 2: unchanged Prograf® dose since the last two therapeutic drug
monitorings (TDM)
5. Patient for whom the decision is made to switch from Prograf® to Envarsus®
6. Written informed consent obtained prior to any study-related procedure
7. Patient with tacrolimus C0 between 4 and 12 µg/L at V1
8. Patient with hematocrit > 27% at V1
1. Patient presenting any contra-indication to tacrolimus according to the summary of
product characteristics (SmPC) of Envarsus®
2. Recipient of any transplanted organ other than kidney or liver
3. Patient treated by Prograf® for less than 7 days at enrolment
4. Patient previously treated by any other investigational agent if it is not stopped
at least 7 days prior to enrolment
5. Pregnant or lactating woman (based on declaration)
6. Patient under judicial protection
7. Patient incapable of understanding the purposes and risks of the study, who cannot
give written informed consent, or who are unwilling to comply with the study
protocol.