Allograft Clinical Trial
— ENVARSWITCHOfficial title:
Pharmacokinetic Assessment of Tacrolimus Exposure Before and After a Switch From Twice Daily Immediate-release (Prograf®) to Once-daily Prolonged Release Tacrolimus (Envarsus®)
NCT number | NCT02882828 |
Other study ID # | I160015 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | October 2016 |
Est. completion date | December 2020 |
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.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | December 2020 |
Est. primary completion date | May 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 Exclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
France | University Hospital of Amiens | Amiens | |
France | University Hospital of Bordeaux | Bordeaux | |
France | University Hospital of Lille | Lille | |
France | Limoges Hospital | Limoges | |
France | AP-HP | Paris | |
France | University Hospital of Poitiers | Poitiers | |
France | University Hospital of Reims | Reims | |
France | University Hospital of Rouen | Rouen | |
France | University Hospital of Tours | Tours |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Limoges |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference between the post-switch tacrolimus steady-state AUC0-24h (V4) and the pre-switch AUC0-24h (V2). | The tacrolimus AUC0-24h at V2 (patient on Prograf®) will be calculated by summing the morning and the evening tacrolimus AUC0-12h. | 3 days |
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