Clinical trial NCT02143479: A Multicenter Study in Liver Transplant Patients Converted From Prograf® to Advagraf® During the First Post-transplantation Year
Official title: A Cohort Study in Liver Transplant Patients Converted From a Tacrolimus Twice a Day (Prograf®) to Tacrolimus Once a Day (Advagraf®). French, Multisite, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Keywords: France
Prograf
Pharmaco-epidemiology
Tacrolimus
Observational
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-05-21
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Liver transplant patients

Brief summary: A study in which two groups of patients will be analysed; patients converted from Prograf to Advagraf within the first 3 months after transplantation and patients converted from Prograf to Advagraf between 3 months and 1 year after transplantation.


Eligibility criteria: Inclusion Criteria:

* Patient with a liver transplant performed in the previous year and for whom the conversion from Prograf® to Advagraf® was decided by the physician.

Exclusion Criteria:

* Patient participating in an interventional clinical trial at the time of enrolment into the study.

Primary outcomes:
measure: Conversion ratio of the daily dose of tacrolimus (mg Prograf® / mg Advagraf®)
timeFrame: At baseline
measure: Time of the first tacrolimus trough level (C0) after conversion
timeFrame: From baseline to first determination of C0 (up to 6 months)
measure: Number of additional visits considered by the physicians to be due to the conversion (if required)
timeFrame: At 6 months and at 1 year follow-up visit
Secondary outcomes:
measure: Reasons for conversion
timeFrame: At baseline
measure: Patient profile
timeFrame: At baseline
measure: Collection of immunosuppressive protocol details
timeFrame: At baseline, 6 months and 1 year follow-up visit
measure: Time to reach steady state
timeFrame: From baseline to first determination of C0 (up to 6 months)
measure: Dose ratio at steady state
timeFrame: From baseline and up to 6 months post-conversion
measure: The Intra -Patient Variability (IPV) of tacrolimus in patients on Prograf® and Advagraf ®
timeFrame: At baseline (Prograf) and during the 45 days after conversion (Advagraf)
measure: Latest available laboratory data with Prograf® before conversion and with Advagraf®
timeFrame: At baseline, 6 months and 1 year follow-up visit
measure: Compliance with treatment at conversion
timeFrame: At baseline and at 1 year after conversion
measure: Patients' quality of life at conversion
timeFrame: At baseline and at 1 year after conversion
measure: Rate of acute rejection proven by biopsy (BPAR), graft survival rate and patient survival rate
timeFrame: 6 months and 1 year
measure: Occurrence of adverse events and/or effects
timeFrame: From baseline until 1 year follow-up visit
Other outcomes:
Locations:
city: Besancon
country: France
facility: Site
city: Bordeaux
country: France
facility: Site
city: Caen
country: France
facility: Site
city: Chambray les Tours
country: France
facility: Site
city: Clichy
country: France
facility: Site
city: Creteil
country: France
facility: Site
city: Grenoble
country: France
facility: Site
city: Lille
country: France
facility: Site
city: Limoges
country: France
facility: Site
city: Lyon 3
country: France
facility: Site
city: Lyon 4
country: France
facility: Site
city: Marseille
country: France
facility: Site
city: Montpellier
country: France
facility: Site
city: Nice
country: France
facility: Site
city: Paris
country: France
facility: Site
city: Rennes
country: France
facility: Site
city: Toulouse
country: France
facility: Site
city: Villejuif
country: France
facility: Site
Study officials:
affiliation: Astellas Pharma S.A.S.
name: Medical and Scientific Affairs Manager, Transplantation
role: STUDY_DIRECTOR
References: