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Completed

NCT Number: NCT02143479

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

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.

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Key information

Conditions

Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site, Besançon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tacrolimus

Drug

oral

Other names: FK506, Prograf, Advagraf

Primary outcomes

  1. Conversion ratio of the daily dose of tacrolimus (mg Prograf® / mg Advagraf®)

    Time frame: At baseline

    Percentage of patients with a conversion ratio of tacrolimus dose of 1mg/1mg and percentage of patients with a ratio differing from 1mg/1mg

  2. 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 days between the conversion date and the date of the first determination of C0 after conversion

  3. 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

    Percentage of patients with additional visit(s) and percentage of patients without an additional visit

Secondary outcomes

  1. Reasons for conversion

    Time frame: At baseline

    Number of pills, number of treatment intake, treatment compliance, physician request, patient request, safety of treatment, center practice

  2. Patient profile

    Time frame: At baseline

    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

  3. Collection of immunosuppressive protocol details

    Time frame: At baseline, 6 months and 1 year follow-up visit

    • 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

  4. Time to reach steady state

    Time frame: From baseline to first determination of C0 (up to 6 months)

  5. Dose ratio at steady state

    Time frame: From baseline and up to 6 months post-conversion

    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

  6. 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)

  7. Latest available laboratory data with Prograf® before conversion and with Advagraf®

    Time frame: At baseline, 6 months and 1 year follow-up visit

    Values and dates for renal parameters, liver parameters, blood glucose and Hepatitis C viral load

  8. Compliance with treatment at conversion

    Time frame: At baseline and at 1 year after 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

  9. Patients' quality of life at conversion

    Time frame: At baseline and at 1 year after 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

  10. Rate of acute rejection proven by biopsy (BPAR), graft survival rate and patient survival rate

    Time frame: 6 months and 1 year

    Will be assessed on the basis of the number of acute rejections confirmed by biopsy and recorded adverse events and adverse reactions

  11. Occurrence of adverse events and/or effects

    Time frame: From baseline until 1 year follow-up visit

Sponsors and collaborators

Lead sponsor

Astellas Pharma S.A.S.

Industry

Registry information

Official study 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

Acronym: COBALT

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 21, 2014
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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