Trial · NCT02143479
A Multicenter Study in Liver Transplant Patients Converted From Prograf® to Advagraf® During the First Post-transplantation Year
NCT02143479, Completed, Astellas Pharma S.A.S.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Multicenter Study in Liver Transplant Patients Converted From Prograf® to Advagraf® During the First Post-transplantation Year. Trials, record NCT02143479. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02143479
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multicenter Study in Liver Transplant Patients Converted From Prograf® to Advagraf® During the First Post-transplantation Year
- NCT number
- NCT02143479
- Status
- Completed
- Enrollment
- 398 participants, actual
- Lead sponsor
- Astellas Pharma S.A.S.
- Conditions
- Liver Transplantation
- Interventions
- Tacrolimus
- First posted
- 2014-05-21
- Last updated
- 2024-10-21
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Conversion ratio of the daily dose of tacrolimus (mg Prograf® / mg Advagraf®) | 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 |
| Primary | Time of the first tacrolimus trough level (C0) after conversion | 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 |
| Primary | Number of additional visits considered by the physicians to be due to the conversion (if required) | 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 | Reasons for conversion | At baseline | Number of pills, number of treatment intake, treatment compliance, physician request, patient request, safety of treatment, center practice |
| Secondary | Patient profile | 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 |
| Secondary | Collection of immunosuppressive protocol details | 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 |
| Secondary | Time to reach steady state | From baseline to first determination of C0 (up to 6 months) | |
| Secondary | Dose ratio at steady state | 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 |
| Secondary | The Intra -Patient Variability (IPV) of tacrolimus in patients on Prograf® and Advagraf ® | At baseline (Prograf) and during the 45 days after conversion (Advagraf) | |
| Secondary | Latest available laboratory data with Prograf® before conversion and with Advagraf® | 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 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02143479
GET https://conductscience.org/api/trials/v1/NCT02143479/registered