A Multicenter Study in Liver Transplant Patients Converted From Prograf® to Advagraf® During the First Post-transplantation Year
COBALT
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
1 other identifier
observational
398
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2014
Typical duration for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2014
CompletedFirst Posted
Study publicly available on registry
May 21, 2014
CompletedStudy Start
First participant enrolled
June 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 3, 2017
CompletedOctober 21, 2024
March 1, 2019
2.9 years
May 9, 2014
October 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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)
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 Outcomes (11)
Reasons for conversion
At baseline
Patient profile
At baseline
Collection of immunosuppressive protocol details
At baseline, 6 months and 1 year follow-up visit
Time to reach steady state
From baseline to first determination of C0 (up to 6 months)
Dose ratio at steady state
From baseline and up to 6 months post-conversion
- +6 more secondary outcomes
Study Arms (2)
1:early conversion from Prograf® to Advagraf®
patients converted from Prograf® to Advagraf® in the first 3 months after transplantation
2:late conversion from Prograf® to Advagraf®
patients converted from Prograf® to Advagraf® between 3 months and one year after transplantation
Interventions
oral
Eligibility Criteria
Liver transplant patients
You may qualify if:
- Patient with a liver transplant performed in the previous year and for whom the conversion from Prograf® to Advagraf® was decided by the physician.
You may not qualify if:
- Patient participating in an interventional clinical trial at the time of enrolment into the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Site
Besançon, France
Site
Bordeaux, France
Site
Caen, France
Site
Chambray-lès-Tours, France
Site
Clichy, France
Site
Créteil, France
Site
Grenoble, France
Site
Lille, France
Site
Limoges, France
Site
Lyon, France
Site
Marseille, France
Site
Montpellier, France
Site
Nice, France
Site
Paris, France
Site
Rennes, France
Site
Toulouse, France
Site
Villejuif, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical and Scientific Affairs Manager, Transplantation
Astellas Pharma S.A.S.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2014
First Posted
May 21, 2014
Study Start
June 18, 2014
Primary Completion
May 3, 2017
Study Completion
May 3, 2017
Last Updated
October 21, 2024
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share
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/.