Overview

This trial is active, not recruiting.

Condition liver transplantation
Treatments prograf, advagraf
Sponsor Astellas Pharma S.A.S.
Start date June 2014
End date March 2017
Trial size 400 participants
Trial identifier NCT02143479, FR-ADV-NI-002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
patients converted from Prograf® to Advagraf® in the first 3 months after transplantation
prograf FK506
oral
advagraf FK506E
oral
patients converted from Prograf® to Advagraf® between 3 months and one year after transplantation
prograf FK506
oral
advagraf FK506E
oral

Primary Outcomes

Measure
Conversion ratio of the daily dose of tacrolimus (mg Prograf® / mg Advagraf®)
time frame: At baseline
Time of the first tacrolimus trough level (C0) after conversion
time frame: From baseline to first determination of C0 (up to 6 months)
Number of additional visits considered by the physicians to be due to the conversion (if required)
time frame: At 6 months and at 1 year follow-up visit

Secondary Outcomes

Measure
Reasons for conversion
time frame: At baseline
Patient profile
time frame: At baseline
Collection of immunosuppressive protocol details
time frame: At baseline, 6 months and 1 year follow-up visit
Time to reach steady state
time frame: From baseline to first determination of C0 (up to 6 months)
Dose ratio at steady state
time frame: From baseline and up to 6 months post-conversion
The Intra -Patient Variability (IPV) of tacrolimus in patients on Prograf® and Advagraf ®
time frame: At baseline (Prograf) and during the 45 days after conversion (Advagraf)
Latest available laboratory data with Prograf® before conversion and with Advagraf®
time frame: At baseline, 6 months and 1 year follow-up visit
Compliance with treatment at conversion
time frame: At baseline and at 1 year after conversion
Patients' quality of life at conversion
time frame: At baseline and at 1 year after conversion
Rate of acute rejection proven by biopsy (BPAR), graft survival rate and patient survival rate
time frame: 6 months and 1 year
Occurrence of adverse events and/or effects
time frame: From baseline until 1 year follow-up visit

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Astellas Pharma Inc.