Liver Transplantation
Conditions
Keywords
France, Prograf, Pharmaco-epidemiology, Tacrolimus, Observational
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.
Interventions
DRUGTacrolimus
oral
Sponsors
Astellas Pharma S.A.S.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conversion ratio of the daily dose of tacrolimus (mg Prograf® / mg Advagraf®) | At baseline | 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 of the first tacrolimus trough level (C0) after conversion | From baseline to first determination of C0 (up to 6 months) | Number of days between the conversion date and the date of the first determination of C0 after conversion |
| Number of additional visits considered by the physicians to be due to the conversion (if required) | At 6 months and at 1 year follow-up visit | Percentage of patients with additional visit(s) and percentage of patients without an additional visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to reach steady state | From baseline to first determination of C0 (up to 6 months) | — |
| Dose ratio at steady state | From baseline and up to 6 months post-conversion | Ratio of daily dose of tacrolimus during achievement of steady state: mg Prograf® at conversion/mg Advagraf® during achievement of steady state. Percentage of patients with a ratio of 1mg/1mg and percentage of patients with a ratio differing from 1mg/1mg |
| The Intra -Patient Variability (IPV) of tacrolimus in patients on Prograf® and Advagraf ® | At baseline (Prograf) and during the 45 days after conversion (Advagraf) | — |
| Latest available laboratory data with Prograf® before conversion and with Advagraf® | At baseline, 6 months and 1 year follow-up visit | Values and dates for renal parameters, liver parameters, blood glucose and Hepatitis C viral load |
| Reasons for conversion | At baseline | Number of pills, number of treatment intake, treatment compliance, physician request, patient request, safety of treatment, center practice |
| Patients' quality of life at conversion | At baseline and at 1 year after conversion | Patients' quality of life at conversion (with Prograf® only in group 2) and at 1 year after conversion (with Advagraf® for both groups) will be assessed using the European Quality of Life-5 Dimensions 5 level (EQ5D-5L) questionnaire |
| Rate of acute rejection proven by biopsy (BPAR), graft survival rate and patient survival rate | 6 months and 1 year | Will be assessed on the basis of the number of acute rejections confirmed by biopsy and recorded adverse events and adverse reactions |
| Occurrence of adverse events and/or effects | From baseline until 1 year follow-up visit | — |
| Compliance with treatment at conversion | At baseline and at 1 year after conversion | Compliance with treatment at conversion (with Prograf® and only in group 2) and at 1 year after conversion (with Advagraf® for both groups) will be assessed using the Morisky questionnaire and a score will be calculated |
| Patient profile | At baseline | 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 |
| Collection of immunosuppressive protocol details | At baseline, 6 months and 1 year follow-up visit | * 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 |
Countries
France
Outcome results
None listed