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

Completed

• Conditions: Renal Transplantation
• Interventions: Drug: Tacrolimus

• Registration Number: NCT02147938
• Lead Sponsor: Astellas Pharma S.A.S.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-15
• Study First Submitted QC: 2014-05-23
• Study First Posted: 2014-05-28
• Study Start: 2014-07-17
• Primary Completion: 2017-05-15
• Study Completion: 2017-05-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 578

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1: early conversion from Prograf® to Advagraf®	Tacrolimus	patients converted during the first 6 months post-transplantation
2: late conversion from Prograf® to Advagraf®	Tacrolimus	patients converted between 6 and 12 months post-transplantation

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Time to reach steady state	Time from baseline (conversion) to steady state C0 assessed up to one year
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.
Reasons for the conversion	At baseline	number of capsules, poor treatment compliance, requested by patient, safety, centre practice, other
The intra-patient variability (IPV) of tacrolimus	At baseline and up to 6 months post-baseline
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)
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
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
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
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

Trial Locations

Locations (1)

Site; 🇫🇷 Tours, France