A Multicenter Study in Liver Transplant Patients Converted From Prograf® to Advagraf® During the First Post-transplantation Year

Astellas Pharma S.A.S.398 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

398

Conditions

Liver Transplantation

Interventions

TacrolimusDRUG

oral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (18)

Site

Besançon, France

Site

Bordeaux, France

Site

Caen, France

Outcomes

Primary Outcomes

Conversion ratio of the daily dose of tacrolimus (mg Prograf® / mg Advagraf®)

Percentage of patients with a conversion ratio of tacrolimus dose of 1mg/1mg and percentage of patients with a ratio differing from 1mg/1mg

Time frame: At baseline

Time of the first tacrolimus trough level (C0) after conversion

Number of days between the conversion date and the date of the first determination of C0 after conversion

Time frame: From baseline to first determination of C0 (up to 6 months)

Number of additional visits considered by the physicians to be due to the conversion (if required)

Percentage of patients with additional visit(s) and percentage of patients without an additional visit

Time frame: At 6 months and at 1 year follow-up visit

Secondary Outcomes

Reasons for conversion

Number of pills, number of treatment intake, treatment compliance, physician request, patient request, safety of treatment, center practice

Time frame: At baseline

Patient profile

Sociodemographic data, history of transplantation, comorbidities, complications after transplantation, risk factors, concomitant treatments (other than immunosuppressive protocols) and modification, if required, at 6 months and 1 year after conversion

Time frame: At baseline

Collection of immunosuppressive protocol details

* Date of initiation of treatment with Advagraf® * Target tacrolimus C0 (with Prograf® and with Advagraf® and recommendations for administration) * Daily dose of Advagraf® * Adjustments to Advagraf® dose since the previous visit: date, doses and reason for adjustment * Type and dose of immunosuppressive drugs combined with Advagraf® * Modification of the immunosuppressive regimen at 6 months and 1 year after conversion (if applicable) since the previous visit: date, modified treatment, type of modification, reason for modification * Immunosuppressive regimen at the end of the visit at 6 months and 1 year after conversion, modified treatment, type of modification, reason for modification

Data from ClinicalTrials.gov

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