Liver TransplantationCOBALTNCT02143479
A Multicenter Study in Liver Transplant Patients Converted From Prograf® to Advagraf® During the First Post-transplantation Year
An observational study of Liver Transplantation, run by Astellas Pharma S.A.S. at 18 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Tacrolimus
- Type of treatment
- Pill or oral medicine
- How many people
- 398 participants
- Where
- 18 sitesFrance
- Study dates
- 18 Jun 2014to 3 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Liver transplant patients
Who may be able to join
- Patient with a liver transplant performed in the previous year and for whom the conversion from Prograf® to Advagraf® was decided by the physician.
Who cannot join
- Patient participating in an interventional clinical trial at the time of enrolment into the study.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
Site
Besançon
Site
Bordeaux
Site
Caen
Site
Chambray-lès-Tours
Site
Clichy
Site
Créteil
Site
Grenoble
Site
Lille
Site
Limoges
Site
Lyon 03
Site
Lyon 04
Site
Marseille
Site
Montpellier
Site
Nice
Site
Paris
Site
Rennes
Site
Toulouse
Site
Villejuif
About this study
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
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.
- Conditions
- Liver Transplantation
- Being tested
- Tacrolimus
- Keywords
- France, Prograf, Pharmaco-epidemiology, Tacrolimus, Observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called FK506, Prograf, Advagraf
oral
| Study group | Role | What they receive |
|---|---|---|
| 1:early conversion from Prograf® to Advagraf® | patients converted from Prograf® to Advagraf® in the first 3 months after transplantation Receives: Drug: Tacrolimus | |
| 2:late conversion from Prograf® to Advagraf® | patients converted from Prograf® to Advagraf® between 3 months and one year after transplantation Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline
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
Measured: 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)
Percentage of patients with additional visit(s) and percentage of patients without an additional visit
Measured: At 6 months and at 1 year follow-up visit
Secondary outcomes (11)
Reasons for conversion
Number of pills, number of treatment intake, treatment compliance, physician request, patient request, safety of treatment, center practice
Measured: At baseline
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
Measured: At baseline
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
Measured: At baseline, 6 months and 1 year follow-up visit
Time to reach steady state
Measured: From baseline to first determination of C0 (up to 6 months)
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
Measured: From baseline and up to 6 months post-conversion
The Intra -Patient Variability (IPV) of tacrolimus in patients on Prograf® and Advagraf ®
Measured: At baseline (Prograf) and during the 45 days after conversion (Advagraf)
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
Measured: At baseline, 6 months and 1 year follow-up visit
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
Measured: At baseline and at 1 year after conversion
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
Measured: At baseline and at 1 year after conversion
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
Measured: 6 months and 1 year
Occurrence of adverse events and/or effects
Measured: From baseline until 1 year follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study start18 Jun 2014
- Primary completion3 May 2017
- Study completion3 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma S.A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical and Scientific Affairs Manager, Transplantation, Study director, Astellas Pharma S.A.S.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143479
- Sponsor's protocol ID
- FR-ADV-NI-002
- Acronym
- COBALT
- Status last verified
- Mar 2019
- First submitted
- 9 May 2014
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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/.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02143479
- Acronym / sponsor ID
- COBALT / FR-ADV-NI-002
- Conditions
- Liver Transplantation
- Keywords
- France, Prograf, Pharmaco-epidemiology, Tacrolimus, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Astellas Pharma S.A.S.Industry (pharma, biotech, devices)
- Study start
- 18 Jun 2014 (actual)
- Primary completion
- 3 May 2017 (actual)
- Study completion
- 3 May 2017 (actual)
- First posted
- 21 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1:early conversion from Prograf® to Advagraf® | – | Drug: Tacrolimuspatients converted from Prograf® to Advagraf® in the first 3 months after transplantation |
| 2:late conversion from Prograf® to Advagraf® | – | Drug: Tacrolimuspatients converted from Prograf® to Advagraf® between 3 months and one year after transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Liver transplant patients
Key inclusion criteria (1 listed)
- Patient with a liver transplant performed in the previous year and for whom the conversion from Prograf® to Advagraf® was decided by the physician.
Key exclusion criteria (1 listed)
- Patient participating in an interventional clinical trial at the time of enrolment into the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TacrolimusAlso: FK506, Prograf, Advagraforal | Drug | 1:early conversion from Prograf® to Advagraf®, 2:late conversion from Prograf® to Advagraf® |
Primary outcome
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
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
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
11 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: No. 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/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical and Scientific Affairs Manager, Transplantation study director
Astellas Pharma S.A.S.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation, run by Astellas Pharma S.A.S. at 18 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion ratio of the daily dose of tacrolimus (mg Prograf® / mg Advagraf®) (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.