PK Assessment of Tacrolimus Exposure Before and After a Switch From Twice Daily Immediate-release (Prograf®) to Once-daily Prolonged Release Tacrolimus (Envarsus®)

Last updated: May 13, 2025
Sponsor: University Hospital, Limoges
Overall Status: Completed

Phase

4

Condition

Organ Transplant

Treatment

switched from Prograf® to Envarsus®

Clinical Study ID

NCT02882828
I160015
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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, applycriterion #2

  • Criterion 2: unchanged Prograf® dose since the last two therapeutic drugmonitorings (TDM)

  1. Patient for whom the decision is made to switch from Prograf® to Envarsus®

  2. Written informed consent obtained prior to any study-related procedure

  3. Patient with tacrolimus C0 between 4 and 12 µg/L at V1

  4. Patient with hematocrit > 27% at V1

Exclusion

Exclusion Criteria:

  1. Patient presenting any contra-indication to tacrolimus according to the summary ofproduct 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 stoppedat 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 cannotgive written informed consent, or who are unwilling to comply with the studyprotocol.

Study Design

Total Participants: 140
Treatment Group(s): 1
Primary Treatment: switched from Prograf® to Envarsus®
Phase: 4
Study Start date:
October 01, 2016
Estimated Completion Date:
March 31, 2020

Connect with a study center

  • University Hospital of Amiens

    Amiens,
    France

    Site Not Available

  • University Hospital of Bordeaux

    Bordeaux,
    France

    Site Not Available

  • University Hospital of Lille

    Lille,
    France

    Site Not Available

  • Limoges Hospital

    Limoges, 87 042
    France

    Site Not Available

  • AP-HP

    Paris,
    France

    Site Not Available

  • University Hospital of Poitiers

    Poitiers,
    France

    Site Not Available

  • University Hospital of Reims

    Reims,
    France

    Site Not Available

  • University Hospital of Rouen

    Rouen,
    France

    Site Not Available

  • University Hospital of Tours

    Tours,
    France

    Site Not Available

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