Trial reportClinical transplantation2015
Switching STudy of Kidney TRansplant PAtients with Tremor to LCP-TacrO (STRATO): an open-label, multicenter, prospective phase 3b study.
Trial report in Clinical transplantation, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 58 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Conversion From Immediate Release Tacrolimus to Envarsus XR® in Simultaneous Pancreas-Kidney Recipients: Assessment of Functional, Safety and Quality of Life Outcomes (CIRTEN SPK)
A 12 Month Single-center, Open Label, Randomized, Comparative Study to Evaluate Envarsus XL Steroid-free Rabbit Anti-thymocyte Globulin Induction on Renal Function and Health-related Quality of Life Following Liver Transplantation
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
Efficacy of Envarsus XR and Digital Health Technology in Reducing Tacrolimus Fluctuation and Frequency of Dose Changes
Who cites it
58 citing papers in PubMed, 1 synthesis or guideline pooled it, 113 citations in OpenAlex.
- Efficacy and safety of once-daily prolonged-release tacrolimus versus twice-daily tacrolimus in kidney transplant recipients: A meta-analysis and trial sequential analysis.Journal of the Chinese Medical Association : JCMA · 2023Pooled it
- Tremors and Health-Related Quality of Life in Liver Transplant Recipients: Post-hoc Analysis of a Multicenter, Randomized, Controlled Trial Comparing a Life Cycle Pharma-Tacrolimus Regimen and Extended-Release Tacrolimus Regimen.Transplant international : official journal of the European Society for Organ Transplantation · 2025Trial
- Tremor, Daily Functioning, and Health-Related Quality of Life in Solid Organ Transplant Recipients.Transplant international : official journal of the European Society for Organ Transplantation · 2023Trial
- A randomized crossover study comparing different tacrolimus formulations to reduce intrapatient variability in tacrolimus exposure in kidney transplant recipients.Clinical and translational science · 2022Trial
- Pharmacokinetics of Once-Daily Extended-Release Tacrolimus Tablets Versus Twice-Daily Capsules in De Novo Liver Transplant.Clinical pharmacology in drug development · 2019Trial
- Pharmacokinetics of Prolonged-Release Once-Daily Formulations of Tacrolimus in De Novo Kidney Transplant Recipients: A Randomized, Parallel-Group, Open-Label, Multicenter Study.Advances in therapy · 2019Trial
- Evaluation of Flexible Tacrolimus Drug Concentration Monitoring Approach in Patients Receiving Extended-Release Once-Daily Tacrolimus Tablets.Journal of clinical pharmacology · 2018Trial
- 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
- Impact of Azole Antifungals on the Conversion Ratio of Immediate-release Tacrolimus to LCP-Tacrolimus Tablets in Non-kidney Solid Organ Transplant Recipients.Transplantation direct · 2026Article
- Dosing, Safety, and Tolerability of Extended-Release Tacrolimus in Pediatric and Young Adult Solid Organ Transplant Recipients.Pediatric transplantation · 2026Article
- Post-Transplant Tremor: Characteristics and Differences Based on Sex and Post-Transplant Therapy.Neurology international · 2026Article
- Financial burden of once daily extended-release tacrolimus and twice daily immediate-release tacrolimus for kidney transplant recipients.Exploratory research in clinical and social pharmacy · 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
- Establishment of accurate estimation equations for area under the concentration curves using simultaneous limited sampling for extended-release tacrolimus and mycophenolic acid in kidney transplant recipients.Frontiers in immunology · 2026Article
- Comparative neuropsychiatric safety signals of tacrolimus versus cyclosporine in solid organ transplantation: ten-year FAERS pharmacovigilance study.Frontiers in immunology · 2026Article
- Smartphone-measured tremor and tacrolimus trough levels in kidney transplant recipients: an exploratory prospective study.Frontiers in transplantation · 2026Article
- Tacrolimus toxicity in kidney transplant recipient after wedge liver resection: A case report and review of literature.World journal of nephrology · 2025Article
- Early Conversion to Once-Daily MeltDoseJournal of clinical medicine · 2025Article
- The predictive value of tacrolimus intrapatient variability and time in therapeutic range for renal transplant outcomes.Renal failure · 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
9 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Tremor is a common side effect of tacrolimus correlated with peak-dose drug concentration. LCPT, a novel, once-daily, extended-release formulation of tacrolimus, has a reduced Cmax with comparable AUC exposure, requiring a ~30% dose reduction vs. immediate-release tacrolimus. In this phase 3b study, kidney transplant recipients (KTR) on a stable dose of tacrolimus and with a reported clinically significant tremor were offered a switch to LCPT. Tremor pre- and seven d post-conversion was evaluated by independent, blinded movement disorder neurologists using the Fahn-Tolosa-Marin (FTM) scale and by an accelerometry device; patients completed the QUEST (quality of life in essential tremor) and the Patient Global Impression of Change. There were 38 patients in the mITT population. A statistically and clinically significant improvement in tremor (FTM score, amplitude as measured by the accelerometry device and QOL [p-values < 0.05]) resulted post-conversion. Change in QUEST was significantly (p = 0.006) correlated (R = 0.44) with change in FTM; 78.9% of patients reported an improvement after switching to LCPT (p < 0.0005). To our knowledge this is the first trial in KTR that utilizes a sophisticated and reproducible measurement of tremor. Results suggest LCPT is associated with clinically meaningful improvement of hand tremor and may be an alternative management approach in lieu of further dose reduction of immediate-release tacrolimus for patients experiencing tremor.
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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.