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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1:early conversion from Prograf® to Advagraf® | patients converted from Prograf® to Advagraf® in the first 3 months after transplantation |
| |
| 2:late conversion from Prograf® to Advagraf® | patients converted from Prograf® to Advagraf® between 3 months and one year after transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | At 6 months and at 1 year follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Reasons for conversion | Number of pills, number of treatment intake, treatment compliance, physician request, patient request, safety of treatment, center practice | At baseline |
| Patient profile |
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Inclusion Criteria:
Exclusion Criteria:
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Liver 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 | Besançon | 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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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
| At baseline |
| Collection of immunosuppressive protocol details |
| At baseline, 6 months and 1 year follow-up visit |
| Time to reach steady state | From baseline to first determination of C0 (up to 6 months) |
| Dose ratio at steady state | 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 | From baseline and up to 6 months post-conversion |
| 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® | Values and dates for renal parameters, liver parameters, blood glucose and Hepatitis C viral load | At baseline, 6 months and 1 year follow-up visit |
| Compliance with treatment at 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 | At baseline and at 1 year after conversion |
| Patients' quality of life at 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 | At baseline and at 1 year after conversion |
| Rate of acute rejection proven by biopsy (BPAR), graft survival rate and patient survival rate | Will be assessed on the basis of the number of acute rejections confirmed by biopsy and recorded adverse events and adverse reactions | 6 months and 1 year |
| Occurrence of adverse events and/or effects | From baseline until 1 year follow-up visit |
| Bordeaux |
| France |
| Site | Caen | France |
| Site | Chambray-lès-Tours | France |
| Site | Clichy | France |
| Site | Créteil | France |
| Site | Grenoble | France |
| Site | Lille | France |
| Site | Limoges | France |
| Site | Lyon 03 | France |
| Site | Lyon 04 | France |
| Site | Marseille | France |
| Site | Montpellier | France |
| Site | Nice | France |
| Site | Paris | France |
| Site | Rennes | France |
| Site | Toulouse | France |
| Site | Villejuif | France |
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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