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

Renal Transplantation Clinical Trial

— OPALE  

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®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02147938
• Other study ID #: FR-ADV-NI-003
• Status: Completed
• Start date: July 17, 2014
• Est. completion date: May 15, 2017

Study information

• Verified date: March 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 578
• Est. completion date: May 15, 2017
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Drug:
• Tacrolimus
oral

Locations

Country	Name	City	State
France	Site	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

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma S.A.S.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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	Reasons for the conversion	number of capsules, poor treatment compliance, requested by patient, safety, centre practice, other	At baseline
Secondary	Profile of the patients in both groups	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
Secondary	Time to reach steady state		Time from baseline (conversion) to steady state C0 assessed up to one year
Secondary	Dose ratio at steady state	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
Secondary	The intra-patient variability (IPV) of tacrolimus		At baseline and up to 6 months post-baseline
Secondary	Latest available laboratory data with Prograf® before conversion and with Advagraf®	Values and dates for blood and urine renal parameters, blood glucose	At baseline, 6 months and 1 year follow-up visit
Secondary	Compliance with the treatment at conversion and at 1 year post-conversion	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
Secondary	The quality of life of the patient at conversion and at 1 year post-conversion	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
Secondary	Incidence of biopsy proven acute rejections (BPAR) and survival of the graft and of the patient		At 1 year follow-up visit
Secondary	Occurrence of adverse effects		From baseline until 1 year follow-up visit after baseline (conversion)