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NCT Number: NCT02147938

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

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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Key information

Conditions

Renal Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

Drug

oral

Other names: Advagraf®, Prograf®, FK506

Primary outcomes

  1. Tacrolimus daily dose conversion ratio (mg Prograf® / mg Advagraf®)

    Time frame: 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

  2. Time to measurement of the first trough tacrolimus blood concentration (C0) after conversion

    Time frame: 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

  3. Number of additional visits that the doctor considers to be due to the conversion (if applicable)

    Time frame: 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 outcomes

  1. Reasons for the conversion

    Time frame: At baseline

    number of capsules, poor treatment compliance, requested by patient, safety, centre practice, other

  2. Profile of the patients in both groups

    Time frame: 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

  3. Time to reach steady state

    Time frame: Time from baseline (conversion) to steady state C0 assessed up to one year

  4. Dose ratio at steady state

    Time frame: 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.

  5. The intra-patient variability (IPV) of tacrolimus

    Time frame: At baseline and up to 6 months post-baseline

  6. Latest available laboratory data with Prograf® before conversion and with Advagraf®

    Time frame: At baseline, 6 months and 1 year follow-up visit

    Values and dates for blood and urine renal parameters, blood glucose

  7. Compliance with the treatment at conversion and at 1 year post-conversion

    Time frame: 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

  8. The quality of life of the patient at conversion and at 1 year post-conversion

    Time frame: 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

  9. Incidence of biopsy proven acute rejections (BPAR) and survival of the graft and of the patient

    Time frame: At 1 year follow-up visit

  10. Occurrence of adverse effects

    Time frame: From baseline until 1 year follow-up visit after baseline (conversion)

Sponsors and collaborators

Lead sponsor

Astellas Pharma S.A.S.

Industry

Registry information

Official study title

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®)

Acronym: OPALE

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 28, 2014
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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