Phase
Condition
Organ Transplant
Treatment
switched from Prograf® to Envarsus®
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult (≥ 18 year-old) male and female patients
Recipient of a single kidney or liver allograft
Patient transplanted for more than 2 weeks and less than 1 year at enrolment
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)
Patient for whom the decision is made to switch from Prograf® to Envarsus®
Written informed consent obtained prior to any study-related procedure
Patient with tacrolimus C0 between 4 and 12 µg/L at V1
Patient with hematocrit > 27% at V1
Exclusion
Exclusion Criteria:
Patient presenting any contra-indication to tacrolimus according to the summary ofproduct characteristics (SmPC) of Envarsus®
Recipient of any transplanted organ other than kidney or liver
Patient treated by Prograf® for less than 7 days at enrolment
Patient previously treated by any other investigational agent if it is not stoppedat least 7 days prior to enrolment
Pregnant or lactating woman (based on declaration)
Patient under judicial protection
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
Connect with a study center
University Hospital of Amiens
Amiens,
FranceSite Not Available
University Hospital of Bordeaux
Bordeaux,
FranceSite Not Available
University Hospital of Lille
Lille,
FranceSite Not Available
Limoges Hospital
Limoges, 87 042
FranceSite Not Available
AP-HP
Paris,
FranceSite Not Available
University Hospital of Poitiers
Poitiers,
FranceSite Not Available
University Hospital of Reims
Reims,
FranceSite Not Available
University Hospital of Rouen
Rouen,
FranceSite Not Available
University Hospital of Tours
Tours,
FranceSite Not Available
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