A Study of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf®) to the Once Per Day Form (Advagraf®)

Study Overview
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Brief Summary
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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).

Official Title
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French Multicentre Observational Study of a Prospective Cohort of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf®) to the Once Per Day Form (Advagraf®)

Conditions
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Renal Transplantation

Intervention / Treatment
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* Drug: Tacrolimus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1: early conversion from Prograf® to Advagraf®<br>patients converted during the first 6 months post-transplantation | Drug: Tacrolimus<br>* oral<br>* Other names: FK506;|
| 2: late conversion from Prograf® to Advagraf®<br>patients converted between 6 and 12 months post-transplantation | Drug: Tacrolimus<br>* oral<br>* Other names: FK506;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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France, Tacrolimus, Prograf, Observational, Advagraf