Clinical trial NCT02147938: A Study of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf®) to the Once Per Day Form (Advagraf®)
Official 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®)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Transplantation
Keywords: France
Tacrolimus
Prograf
Observational
Advagraf
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-05-28
Enrollment: 578
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Renal transplant patients

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).


Eligibility criteria: 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

Primary outcomes:
measure: Tacrolimus daily dose conversion ratio (mg Prograf® / mg Advagraf®)
timeFrame: At baseline (i.e. time of conversion)
measure: Time to measurement of the first trough tacrolimus blood concentration (C0) after conversion
timeFrame: From baseline (conversion) to first determination of C0 assessed up to one year
measure: Number of additional visits that the doctor considers to be due to the conversion (if applicable)
timeFrame: At 6 months and at 1 year follow-up visit
Secondary outcomes:
measure: Reasons for the conversion
timeFrame: At baseline
measure: Profile of the patients in both groups
timeFrame: At baseline
measure: Time to reach steady state
timeFrame: Time from baseline (conversion) to steady state C0 assessed up to one year
measure: Dose ratio at steady state
timeFrame: At baseline (conversion) and up to 6 months post-baseline
measure: The intra-patient variability (IPV) of tacrolimus
timeFrame: At baseline and up to 6 months post-baseline
measure: Latest available laboratory data with Prograf® before conversion and with Advagraf®
timeFrame: At baseline, 6 months and 1 year follow-up visit
measure: Compliance with the treatment at conversion and at 1 year post-conversion
timeFrame: At baseline and 1 year follow-up visit
measure: The quality of life of the patient at conversion and at 1 year post-conversion
timeFrame: At baseline and 1 year follow-up visit
measure: Incidence of biopsy proven acute rejections (BPAR) and survival of the graft and of the patient
timeFrame: At 1 year follow-up visit
measure: Occurrence of adverse effects
timeFrame: From baseline until 1 year follow-up visit after baseline (conversion)
Other outcomes:
Locations:
city: Amiens
country: France
facility: Site
city: Angers
country: France
facility: Site
city: Besancon
country: France
facility: Site
city: Brest
country: France
facility: Site
city: Caen
country: France
facility: Site
city: Clermond-Ferrand
country: France
facility: Site
city: Creteil
country: France
facility: Site
city: Dijon
country: France
facility: Site
city: Le Krémlin-Bicêtre
country: France
facility: Site
city: Lille
country: France
facility: Site
city: Limoges
country: France
facility: Site
city: Lyon 3
country: France
facility: Site
city: Marseille
country: France
facility: Site
city: Montpellier
country: France
facility: Site
city: Nancy
country: France
facility: Site
city: Nantes
country: France
facility: Site
city: Nice
country: France
facility: Site
city: Paris 10
country: France
facility: Site
city: Paris Cedex 13
country: France
facility: Site
city: Poitiers
country: France
facility: Site
city: Rennes
country: France
facility: Site
city: Rouen
country: France
facility: Site
city: Saint Etienne
country: France
facility: Site
city: Strasbourg
country: France
facility: Site
city: Suresnes
country: France
facility: Site
city: Toulouse
country: France
facility: Site
city: Tours
country: France
facility: Site
Study officials:
affiliation: Astellas Pharma S.A.S.
name: Medical and Scientific Affairs Manager, Transplantation
role: STUDY_DIRECTOR
References: