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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: early conversion from Prograf® to Advagraf® | patients converted during the first 6 months post-transplantation |
| |
| 2: late conversion from Prograf® to Advagraf® | patients converted between 6 and 12 months post-transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tacrolimus daily dose conversion ratio (mg Prograf® / mg Advagraf®) | Percentage of patients with a tacrolimus dose conversion ratio of 1mg / 1mg and percentage of patients with a ratio ≠ 1mg / 1mg | At baseline (i.e. time of conversion) |
| Time to measurement of the first trough tacrolimus blood concentration (C0) after conversion | number of days between the date of conversion and the date of first assay of C0 after conversion | From baseline (conversion) to first determination of C0 assessed up to one year |
| Number of additional visits that the doctor considers to be due to the conversion (if applicable) | percentage of patients with additional visit(s) and percentage of patients without additional visit | At 6 months and at 1 year follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Reasons for the conversion | number of capsules, poor treatment compliance, requested by patient, safety, centre practice, other | At baseline |
| Profile of the patients in both groups | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Renal transplant patients
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| Name | Affiliation | Role |
|---|---|---|
| Medical and Scientific Affairs Manager, Transplantation | Astellas Pharma S.A.S. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site | Amiens | France | ||||
| Site |
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| At baseline |
| Time to reach steady state | Time from baseline (conversion) to steady state C0 assessed up to one year |
| Dose ratio at steady state | 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. | At baseline (conversion) and up to 6 months post-baseline |
| 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® | Values and dates for blood and urine renal parameters, blood glucose | At baseline, 6 months and 1 year follow-up visit |
| Compliance with the treatment at conversion and at 1 year post-conversion | 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 | At baseline and 1 year follow-up visit |
| The quality of life of the patient at conversion and at 1 year post-conversion | 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 | At baseline and 1 year follow-up visit |
| 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) |
| Angers |
| France |
| Site | Besançon | France |
| Site | Brest | France |
| Site | Caen | France |
| Site | Clermond-Ferrand | France |
| Site | Créteil | France |
| Site | Dijon | France |
| Site | Le Krémlin-Bicêtre | France |
| Site | Lille | France |
| Site | Limoges | France |
| Site | Lyon 03 | France |
| Site | Marseille | France |
| Site | Montpellier | France |
| Site | Nancy | France |
| Site | Nantes | France |
| Site | Nice | France |
| Site | Paris | France |
| Site | Poitiers | France |
| Site | Rennes | France |
| Site | Rouen | France |
| Site | Saint-Etienne | France |
| Site | Strasbourg | France |
| Site | Suresnes | France |
| Site | Toulouse | France |
| Site | Tours | France |
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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