A Multicenter Study in Liver Transplant Patients Converted From Prograf® to Advagraf® During the First Post-transplantation Year

Liver Transplantation Clinical Trial

— COBALT  

Official title:

A Cohort Study in Liver Transplant Patients Converted From a Tacrolimus Twice a Day (Prograf®) to Tacrolimus Once a Day (Advagraf®). French, Multisite, Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143479
• Other study ID #: FR-ADV-NI-002
• Status: Completed
• Start date: June 18, 2014
• Est. completion date: May 3, 2017

Study information

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

Clinical Trial Summary

A study in which two groups of patients will be analysed; patients converted from Prograf to Advagraf within the first 3 months after transplantation and patients converted from Prograf to Advagraf between 3 months and 1 year after transplantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: May 3, 2017
• Est. primary completion date: May 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with a liver transplant performed in the previous year and for whom the conversion from Prograf® to Advagraf® was decided by the physician.

Exclusion Criteria:

• Patient participating in an interventional clinical trial at the time of enrolment into the study.

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• Tacrolimus
oral

Locations

Country	Name	City	State
France	Site	Besancon
France	Site	Bordeaux
France	Site	Caen
France	Site	Chambray les Tours
France	Site	Clichy
France	Site	Creteil
France	Site	Grenoble
France	Site	Lille
France	Site	Limoges
France	Site	Lyon 3
France	Site	Lyon 4
France	Site	Marseille
France	Site	Montpellier
France	Site	Nice
France	Site	Paris
France	Site	Rennes
France	Site	Toulouse
France	Site	Villejuif

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	Conversion ratio of the daily dose of tacrolimus (mg Prograf® / mg Advagraf®)	Percentage of patients with a conversion ratio of tacrolimus dose of 1mg/1mg and percentage of patients with a ratio differing from 1mg/1mg	At baseline
Primary	Time of the first tacrolimus trough level (C0) after conversion	Number of days between the conversion date and the date of the first determination of C0 after conversion	From baseline to first determination of C0 (up to 6 months)
Primary	Number of additional visits considered by the physicians to be due to the conversion (if required)	Percentage of patients with additional visit(s) and percentage of patients without an additional visit	At 6 months and at 1 year follow-up visit
Secondary	Reasons for conversion	Number of pills, number of treatment intake, treatment compliance, physician request, patient request, safety of treatment, center practice	At baseline
Secondary	Patient profile	Sociodemographic data, history of transplantation, comorbidities, complications after transplantation, risk factors, concomitant treatments (other than immunosuppressive protocols) and modification, if required, at 6 months and 1 year after conversion	At baseline
Secondary	Collection of immunosuppressive protocol details	Date of initiation of treatment with Advagraf®; Target tacrolimus C0 (with Prograf® and with Advagraf® and recommendations for administration); Daily dose of Advagraf®; Adjustments to Advagraf® dose since the previous visit: date, doses and reason for adjustment; Type and dose of immunosuppressive drugs combined with Advagraf®; Modification of the immunosuppressive regimen at 6 months and 1 year after conversion (if applicable) since the previous visit: date, modified treatment, type of modification, reason for modification; Immunosuppressive regimen at the end of the visit at 6 months and 1 year after conversion, modified treatment, type of modification, reason for modification	At baseline, 6 months and 1 year follow-up visit
Secondary	Time to reach steady state		From baseline to first determination of C0 (up to 6 months)
Secondary	Dose ratio at steady state	Ratio of daily dose of tacrolimus during achievement of steady state: mg Prograf® at conversion/mg Advagraf® during achievement of steady state. Percentage of patients with a ratio of 1mg/1mg and percentage of patients with a ratio differing from 1mg/1mg	From baseline and up to 6 months post-conversion
Secondary	The Intra -Patient Variability (IPV) of tacrolimus in patients on Prograf® and Advagraf ®		At baseline (Prograf) and during the 45 days after conversion (Advagraf)
Secondary	Latest available laboratory data with Prograf® before conversion and with Advagraf®	Values and dates for renal parameters, liver parameters, blood glucose and Hepatitis C viral load	At baseline, 6 months and 1 year follow-up visit
Secondary	Compliance with treatment at conversion	Compliance with treatment at conversion (with Prograf® and only in group 2) and at 1 year after conversion (with Advagraf® for both groups) will be assessed using the Morisky questionnaire and a score will be calculated	At baseline and at 1 year after conversion
Secondary	Patients' quality of life at conversion	Patients' quality of life at conversion (with Prograf® only in group 2) and at 1 year after conversion (with Advagraf® for both groups) will be assessed using the European Quality of Life-5 Dimensions 5 level (EQ5D-5L) questionnaire	At baseline and at 1 year after conversion
Secondary	Rate of acute rejection proven by biopsy (BPAR), graft survival rate and patient survival rate	Will be assessed on the basis of the number of acute rejections confirmed by biopsy and recorded adverse events and adverse reactions	6 months and 1 year
Secondary	Occurrence of adverse events and/or effects		From baseline until 1 year follow-up visit