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

October 18, 2024 updated by: Astellas Pharma S.A.S.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
398

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • 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, France
        • SIte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Liver transplant patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
1:early conversion from Prograf® to Advagraf®
patients converted from Prograf® to Advagraf® in the first 3 months after transplantation
Drug: Tacrolimus
oral
Other Names:
  • Prograf
  • FK506
  • Advagraf
2:late conversion from Prograf® to Advagraf®
patients converted from Prograf® to Advagraf® between 3 months and one year after transplantation
Drug: Tacrolimus
oral
Other Names:
  • Prograf
  • FK506
  • Advagraf

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 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)
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
At 6 months and at 1 year follow-up visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
At baseline
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
At baseline
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
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)
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
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
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)
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
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
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
At baseline and at 1 year after conversion
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
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
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
Occurrence of adverse events and/or effects
Time Frame: From baseline until 1 year follow-up visit
From baseline until 1 year follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma S.A.S.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical and Scientific Affairs Manager, Transplantation, Astellas Pharma S.A.S.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 3, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 3, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FR-ADV-NI-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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