Trial · NCT04720326
Bioavailability and Practicability of Envarsus Versus Advagraf in Liver Transplant Recipients
NCT04720326, Phase 4, Completed, Edward Geissler
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bioavailability and Practicability of Envarsus Versus Advagraf in Liver Transplant Recipients. Trials, record NCT04720326. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04720326
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bioavailability and Practicability of Envarsus Versus Advagraf in Liver Transplant Recipients
- NCT number
- NCT04720326
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 268 participants, actual
- Lead sponsor
- Edward Geissler
- Conditions
- Prophylaxis Against Liver Transplant Rejection
- Interventions
- Tacrolimus Pill, Tacrolimus capsule
- First posted
- 2021-01-22
- Last updated
- 2026-11-05
- Other registries' IDs
- eudract:2020-000796-20
Source ClinicalTrials.gov
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-normalised blood trough level of tacrolimus (concentration/dose ratio) | 12 weeks post-randomisation | To calculate C/D ratio, "concentration" is the blood trough level of tacrolimus measured in a blood sample collected immediately prior to drug dosing on the day of the 12-week trial visit and "dose" is the daily dose taken by the patient on the day prior to the visit. C/D ratio is measured as a surrogate for tacrolimus bioavailability (i.e. systemic exposure per mg of drug). |
| Secondary | Number of IMP dose adjustments | Until 12 weeks post-randomisation | |
| Secondary | Time to reach the first defined range in target trough level | Time period measured in days, assessed at 12 weeks post-randomisation | |
| Secondary | Number of measurements above and below the first defined range in target trough level | Time period measured in days, assessed at 12 weeks post-randomisation | |
| Secondary | Dose-normalised trough level (C/D ratio) during long-term follow-up | 1, 2 and 3 years post-randomisation | |
| Secondary | Mean tacrolimus trough level and inter-patient variability (range) of tacrolimus trough levels | 1, 2, 4 and 12 weeks post-randomisation | |
| Secondary | Inter-patient variability (range) of tacrolimus total daily dose | Until 12 weeks post-randomisation | |
| Secondary | Proportion of patients with trough levels lower, within, or higher than the standard reference range | 1, 2, 4 and 12 weeks post-randomisation | |
| Secondary | Incidence and severity of clinically-confirmed biopsy-proven acute rejection | 12 weeks and 1, 2, 3 years post-randomisation | |
| Secondary | Incidence of graft failure (defined as necessity for re-transplantation) | 12 weeks and 1, 2, 3 years post-randomisation |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37170284 | DERIVED |
Source PubMed
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/NCT04720326
GET https://conductscience.org/api/trials/v1/NCT04720326/registered?page=2