Renal Transplantation
Conditions
Keywords
France, Tacrolimus, Prograf, Observational, Advagraf
Brief summary
Assessment in a real situation of the conversion conditions, the efficacy and the safety of the treatment with tacrolimus in renal transplant patients converted from the tacrolimus twice per day form (Prograf®) to the tacrolimus once per day form (Advagraf®) with follow-up at one year. Analysis of two groups of patients: patients converted from Prograf® to Advagraf® early (during the first 6 months post-transplantation) or late (between 6 and 12 months post-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
* Renal transplant patient for less than one year * Patient where the conversion from Prograf® to Advagraf® has been decided by the doctor
Exclusion criteria
* Patient participating in an interventional clinical trial at the time of inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tacrolimus daily dose conversion ratio (mg Prograf® / mg Advagraf®) | At baseline (i.e. time of conversion) | Percentage of patients with a tacrolimus dose conversion ratio of 1mg / 1mg and percentage of patients with a ratio ≠ 1mg / 1mg |
| Time to measurement of the first trough tacrolimus blood concentration (C0) after conversion | From baseline (conversion) to first determination of C0 assessed up to one year | number of days between the date of conversion and the date of first assay of C0 after conversion |
| Number of additional visits that the doctor considers to be due to the conversion (if applicable) | At 6 months and at 1 year follow-up visit | percentage of patients with additional visit(s) and percentage of patients without additional visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose ratio at steady state | At baseline (conversion) and up to 6 months post-baseline | calculation of the tacrolimus daily dose ratio once the steady state is reached: mg Prograf® at conversion / mg Advagraf® once the steady state is reached. Percentage of patients with a ratio of 1mg / 1mg and percentage of patients with a ratio ≠ 1mg / 1mg. |
| The intra-patient variability (IPV) of tacrolimus | At baseline and up to 6 months post-baseline | — |
| 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 blood and urine renal parameters, blood glucose |
| Reasons for the conversion | At baseline | number of capsules, poor treatment compliance, requested by patient, safety, centre practice, other |
| The quality of life of the patient at conversion and at 1 year post-conversion | At baseline and 1 year follow-up visit | The quality of life of the patient at conversion (taking Prograf®) and at 1 year post-conversion (taking Advagraf®) only in group 2 (late conversion) will be assessed using the EQ5D-5L questionnaire |
| Incidence of biopsy proven acute rejections (BPAR) and survival of the graft and of the patient | At 1 year follow-up visit | — |
| Occurrence of adverse effects | From baseline until 1 year follow-up visit after baseline (conversion) | — |
| Compliance with the treatment at conversion and at 1 year post-conversion | At baseline and 1 year follow-up visit | Compliance with the treatment at conversion (taking Prograf®) and at 1 year post-conversion (taking Advagraf®) only in group 2 (late conversion) will be assessed using the Morisky questionnaire, from which a score will be calculated |
| Profile of the patients in both groups | At baseline | sociodemographic data, transplantation history, comorbidities, post-transplantation complications, risk factors and concomitant treatments (Immunosuppressive protocols (IS) and others) at the time of conversion and changes, if applicable, at 6 months and 1 year post-conversion |
| Time to reach steady state | Time from baseline (conversion) to steady state C0 assessed up to one year | — |
Countries
France
Outcome results
None listed