A Study of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf®) to the Once Per Day Form (Advagraf®)
OPALE
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®)
1 other identifier
observational
578
1 country
26
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2014
Typical duration for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2014
CompletedFirst Posted
Study publicly available on registry
May 28, 2014
CompletedStudy Start
First participant enrolled
July 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2017
CompletedNovember 1, 2024
October 1, 2024
2.8 years
May 15, 2014
October 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (10)
Reasons for the conversion
At baseline
Profile of the patients in both groups
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
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
- +5 more secondary outcomes
Study Arms (2)
1: early conversion from Prograf® to Advagraf®
patients converted during the first 6 months post-transplantation
2: late conversion from Prograf® to Advagraf®
patients converted between 6 and 12 months post-transplantation
Interventions
oral
Eligibility Criteria
Renal transplant patients
You may qualify if:
- Renal transplant patient for less than one year
- Patient where the conversion from Prograf® to Advagraf® has been decided by the doctor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Site
Amiens, France
Site
Angers, France
Site
Besançon, France
Site
Brest, France
Site
Caen, France
Site
Clermond-Ferrand, France
Site
Créteil, France
Site
Dijon, France
Site
Le Krémlin-Bicêtre, France
Site
Lille, France
Site
Limoges, France
Site
Lyon, France
Site
Marseille, France
Site
Montpellier, France
Site
Nancy, France
Site
Nantes, France
Site
Nice, France
Site
Paris, 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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical and Scientific Affairs Manager, Transplantation
Astellas Pharma S.A.S.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2014
First Posted
May 28, 2014
Study Start
July 17, 2014
Primary Completion
May 15, 2017
Study Completion
May 15, 2017
Last Updated
November 1, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share
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/.