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

October 30, 2024 updated by: Astellas Pharma S.A.S.

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®)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

578

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • Site
      • Angers, France
        • Site
      • Besancon, France
        • Site
      • Brest, France
        • Site
      • Caen, France
        • Site
      • Clermond-Ferrand, France
        • Site
      • Creteil, France
        • Site
      • Dijon, France
        • Site
      • Le Krémlin-Bicêtre, France
        • Site
      • Lille, France
        • Site
      • Limoges, France
        • Site
      • Lyon 3, France
        • Site
      • Marseille, France
        • Site
      • Montpellier, France
        • Site
      • Nancy, France
        • Site
      • Nantes, France
        • Site
      • Nice, France
        • Site
      • Paris 10, France
        • Site
      • Paris Cedex 13, 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
        • Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Renal transplant patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1: early conversion from Prograf® to Advagraf®
patients converted during the first 6 months post-transplantation
Drug: Tacrolimus
oral
Other Names:
  • FK506
  • Prograf®
  • Advagraf®
2: late conversion from Prograf® to Advagraf®
patients converted between 6 and 12 months post-transplantation
Drug: Tacrolimus
oral
Other Names:
  • FK506
  • Prograf®
  • Advagraf®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline (i.e. time of conversion)
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
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)
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
At 6 months and at 1 year follow-up visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reasons for the conversion
Time Frame: At baseline
number of capsules, poor treatment compliance, requested by patient, safety, centre practice, other
At baseline
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
At baseline
Time to reach steady state
Time Frame: Time from baseline (conversion) to steady state C0 assessed up to one year
Time from baseline (conversion) to steady state C0 assessed up to one year
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.
At baseline (conversion) and up to 6 months post-baseline
The intra-patient variability (IPV) of tacrolimus
Time Frame: At baseline and up to 6 months post-baseline
At baseline and up to 6 months post-baseline
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
At baseline, 6 months and 1 year follow-up visit
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
At baseline and 1 year follow-up visit
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
At baseline and 1 year follow-up visit
Incidence of biopsy proven acute rejections (BPAR) and survival of the graft and of the patient
Time Frame: At 1 year follow-up visit
At 1 year follow-up visit
Occurrence of adverse effects
Time Frame: From baseline until 1 year follow-up visit after baseline (conversion)
From baseline until 1 year follow-up visit after baseline (conversion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma S.A.S.

Investigators

  • Study Director: Medical and Scientific Affairs Manager, Transplantation, Astellas Pharma S.A.S.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2014

Primary Completion (Actual)

May 15, 2017

Study Completion (Actual)

May 15, 2017

Study Registration Dates

First Submitted

May 15, 2014

First Submitted That Met QC Criteria

May 23, 2014

First Posted (Estimated)

May 28, 2014

Study Record Updates

Last Update Posted (Actual)

November 1, 2024

Last Update Submitted That Met QC Criteria

October 30, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FR-ADV-NI-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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/.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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