Trial reportTransplantation2013
Conversion from twice-daily tacrolimus capsules to once-daily extended-release tacrolimus (LCPT): a phase 2 trial of stable renal transplant recipients.
Trial report in Transplantation, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 53 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective, Randomized, Controlled Pilot Study of Early-Use Long Acting Tacrolimus (Envarsus XR) in Lung Transplant Recipients
Evaluation of Early Dose Escalation Using Extended-Release Tacrolimus (Envarsus XR®) to Reduce Acute Rejection and Donor Specific Antibodies in African American Renal Transplant Recipients
Who cites it
53 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- A randomized crossover study comparing different tacrolimus formulations to reduce intrapatient variability in tacrolimus exposure in kidney transplant recipients.Clinical and translational science · 2022Trial
- A single-center, open-label, randomized cross-over study to evaluate the pharmacokinetics and bioavailability of once-daily prolonged-release formulations of tacrolimus in de novo liver transplant recipients.Immunity, inflammation and disease · 2021Trial
- Therapeutic Drug Monitoring Strategies for Envarsus in De Novo Kidney Transplant Patients Using Population Modelling and Simulations.Advances in therapy · 2021Trial
- Pharmacokinetics of Once-Daily Extended-Release Tacrolimus Tablets Versus Twice-Daily Capsules in De Novo Liver Transplant.Clinical pharmacology in drug development · 2019Trial
- Evaluation of Flexible Tacrolimus Drug Concentration Monitoring Approach in Patients Receiving Extended-Release Once-Daily Tacrolimus Tablets.Journal of clinical pharmacology · 2018Trial
- Trough level from twice daily to once daily tacrolimus in early conversion kidney transplant recipients: a prospective study.International journal of clinical pharmacy · 2017Trial
- Population Pharmacokinetics and Bayesian Estimators for Refined Dose Adjustment of a New Tacrolimus Formulation in Kidney and Liver Transplant Patients.Clinical pharmacokinetics · 2017Trial
- A Steady-State Head-to-Head Pharmacokinetic Comparison of All FK-506 (Tacrolimus) Formulations (ASTCOFF): An Open-Label, Prospective, Randomized, Two-Arm, Three-Period Crossover Study.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2017Trial
- Switching STudy of Kidney TRansplant PAtients with Tremor to LCP-TacrO (STRATO): an open-label, multicenter, prospective phase 3b study.Clinical transplantation · 2015Trial
- Factors Associated with Immunosuppressive Adherence in Liver Transplant Recipients Treated with Once- and Twice-Daily Tacrolimus.Medicina (Kaunas, Lithuania) · 2026Article
- Characterising Hand Tremor in Adult Kidney Transplant Recipients: Its Impact on Daily Activities and Relationship With Tacrolimus Administration and Exposure.Nephrology (Carlton, Vic.) · 2026Article
- Envarsus Versus Advagraf in De Novo Kidney Transplant Recipients: A Comparative Pharmacokinetic Study.Life (Basel, Switzerland) · 2026Article
- New-Onset Diabetes After Transplantation in Renal Recipients: A Pilot Comparative Study of Immediate vs. Extended-Release Tacrolimus Formulation.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Tacrolimus-Associated Tremor in Renal Transplant Patients: Potential Impact of the Galenic Formulation.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Optimizing Dose Conversion from IR-Tac to LCP-Tac Formulations in Renal Transplant Recipients: A Population Pharmacokinetic Modeling Study.Pharmaceutics · 2025Article
- Evaluation of Different Initial Doses of Envarsus in De Novo Kidney Transplant Recipients.Journal of clinical medicine · 2025Article
- Calcineurin inhibition may prevent Alzheimer disease in people with Down syndrome.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Review
- Article
- Characterizing the Use of Prolonged-Release Once-Daily Tacrolimus (LCPT) across Canada.The Canadian journal of hospital pharmacy · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLCP-Tacro is an extended-release formulation of tacrolimus designed for once-daily dosing. Phase 1 studies demonstrated greater bioavailability to twice-daily tacrolimus capsules and no new safety concerns.
methodsIn this phase 2 study, adult stable kidney transplant patients on tacrolimus capsules (Prograf) twice-daily were converted to tacrolimus tablets (LCP-Tacro) once-daily; patients continued on LCP-Tacro once-daily for days 8 to 21; trough levels were to be maintained between 5 and 15 ng/mL; 24-hr pharmacokinetic assessments were done on days 7 (baseline pre-switch), 14, and 21.
resultsForty-seven patients completed LCP-Tacro dosing per protocol. The mean conversion ratio was 0.71. Pharmacokinetic data demonstrated consistent exposure (AUC) at the lower conversion dose. C(max) (P = 0.0001), C(max)/C(min) ratio (P < 0.001), percent fluctuation (P < 0.0001), and swing (P = 0.0004) were significantly lower and T(max) significantly (P < 0.001) longer for LCP-Tacro versus Prograf. AUC24 and C(min) correlation coefficients after 7 and 14 days of therapy were 0.86 or more, demonstrating a robust correlation between LCP-Tacro tacrolimus exposure and trough levels. There were three serious adverse events; none were related to study drug and all were resolved.
conclusionsStable kidney transplant patients can be safely converted from Prograf twice-daily to LCP-Tacro. The greater bioavailability of LCP-Tacro allows for once-daily dosing and similar (AUC) exposure at a dose approximately 30% less than the total daily dose of Prograf. LCP-Tacro displays flatter kinetics characterized by significantly lower peak-trough fluctuations.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.