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NCT05744635: LTA
Assessment of the Pharmacokinetic Profile of Tacrolimus Medications and Their Relation to Effectiveness and Safety in Liver Transplant Patients
trial testing Tacrolimus in Liver Failure in 110 participants. Currently enrolling.
1 March 2026
Quick facts
| Lead sponsor | Chiesi Hungary Ltd. |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 110 |
| Start date | 10 May 2023 |
| Primary completion | 1 March 2026 |
| Estimated completion | 1 June 2026 |
| Sites | 2 locations across Slovenia, Hungary |
Drugs / interventions tested
- Tacrolimus (TACROLIMUS) — full drug profile →
Conditions studied
- Liver Failure — all drugs for Liver Failure →
Sponsor
Chiesi Hungary Ltd. — full company profile →
Who can join
18 and older, any sex, with Liver Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this observational study is oo compare the pharmacokinetic parameters of different tacrolimus containing medications in liver transplant patients. The main question\[s\] it aims to answer are: * Differences in pharmacokinetic parameters of tacrolimus containing medicinal products (TL, TDD and their ratio - C/D) * Changes in liver function parameters compared to baseline. * Change in the estimated glomerular filtration rate (eGFR) compared to baseline. * To assess the possible relation of liver function parameters and eGFR to C/D (blood concentration and daily dosage) * Incidence of acute graft rejection during the study * Incidence of BK and cytomegalovirus (CMV) infection during the study * To assess the intraindividual variability of the TL, TDD and the ratios of these parameters (C/D) * To assess the patient-adherence of therapy based on the BAASIS questionnaire, and prescription filled by individual patients, based on electronic health-care record. Participants will not have to undergo any additional clinical visits or tests except which are required in routine clinical care
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05744635
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tacrolimus
Trials testing the same drug.
- NCT07519174 — A Randomized Controlled Trial Comparing the Effectiveness and Safety of Topical Tacrolimus 0.03% Versus Crisaborole 2% i · NA · not yet recruiting
- NCT07249346 — Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease ( · Phase 2 · recruiting
- NCT07349771 — Axatilimab Plus Standard of Care Therapy for the Prevention of Graft Versus Host Disease Following Allogeneic Hematopoie · Phase 2 · not yet recruiting
- NCT06996119 — Emapalumab With Post-Transplant Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Graft-versu · Phase 1 · not yet recruiting
- NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
Other recruiting trials for Liver Failure
Currently open trials in the same condition.
- NCT07312864 — Safety and Tolerability Study of a Novel Bioartificial Liver in Liver Failure and Small-for-Size Syndrome · Phase 1, PHASE2 · recruiting
- NCT06871111 — The Microbiota Augmentation to Reestablish Commensal Organisms (MARCO) Trial · Phase 1 · recruiting
- NCT07053488 — CRISPR-Edited HLA Donor Liver Transplant to Reduce Rejection · Phase 1, PHASE2 · recruiting
- NCT06908746 — Efficacy and Safety of Citrate Anticoagulation in CRRT for Patients With Liver Failure/DysfuncTION, the CAUTION Trial! A · recruiting
- NCT06224023 — Predictive Values of Presepsin Levels in ASciteS in Patients With Chronic Liver Failure · recruiting
Other Chiesi Hungary Ltd. trials
Trials by the same sponsor.
- NCT06840522 — The Importance of Tailored Education And Device Handling for Asthmatic Patients · not yet recruiting
- NCT06678191 — Investigation of Fixed Triple Inhaled Combination in Asthmatic Patients, in a Real-life Setting · recruiting
- NCT05743608 — NEXThaleR Real-world Study Assessing the EffectivenesS of BDP/FF/G Fixed triPle cOmbiNation on Symptom scorEs in COPD Pa · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05744635 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chiesi Hungary Ltd.
- Last refreshed: 22 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05744635.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing