Results of ASERTAA, a Randomized Prospective Crossover Pharmacogenetic Study of Immediate-Release Versus Extended-Release Tacrolimus in African American Kidney Transplant Recipients
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BACKGROUND: Differences in tacrolimus dosing across ancestries is partly attributable to polymorphisms in CYP3A5 genes that encode tacrolimus-metabolizing cytochrome P450 3A5 enzymes. The CYP3A5*1 allele, preponderant in African Americans, is associated with rapid metabolism, subtherapeutic concentrations, and higher dose requirements for tacrolimus, all contributing to worse outcomes. Little is known about the relationship between CYP3A5 genotype and the tacrolimus pharmacokinetic area under the curve (AUC) profile in African Americans or whether pharmacogenetic differences exist between conventional twice-daily, rapidly absorbed, immediate-release tacrolimus (IR-Tac) and once-daily extended-release tacrolimus (LifeCycle Pharma Tac [LCPT]) with a delayed absorption profile. STUDY DESIGN: Randomized prospective crossover study. SETTING & PARTICIPANTS: 50 African American maintenance kidney recipients on stable IR-Tac dosing. INTERVENTION: Recipients were randomly assigned to continue IR-Tac on days 1 to 7 and then switch to LCPT on day 8 or receive LCPT on days 1 to 7 and then switch to IR-Tac on day 8. The LCPT dose was 85% of the IR-Tac total daily dose. OUTCOMES: ), time to peak concentration, and bioavailability of LCPT versus IR-Tac, according to CYP3A5 genotype. MEASUREMENTS: CYP3A5 genotype, 24-hour tacrolimus pharmacokinetic profiles. RESULTS: was 33% higher in CYP3A5 expressers compared with nonexpressers (P=0.04): With LCPT, this difference was 11% (P=0.4). LIMITATIONS: This was primarily a pharmacogenetic study rather than an efficacy study; the follow-up period was too short to capture clinical outcomes. CONCLUSIONS: Achieving therapeutic tacrolimus trough concentrations with IR-Tac in most African Americans results in significantly higher peak concentrations, potentially magnifying the risk for toxicity and adverse outcomes. This pharmacogenetic effect is attenuated by delayed tacrolimus absorption with LCPT. TRIAL REGISTRATION: Registered at ClinicalTrials.gov, with study number NCT01962922.
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A shorter half-life of tacrolimus among kidney transplant recipients compared with healthy volunteers has been demonstrated with IR-Tac.
“In addition, the shorter half-life of tacrolimus among kidney transplant recipients compared with healthy volunteers has also been demonstrated with IR-Tac,13 and a similar observation was made in the current study.”
From Evaluation of Effective Half-Life and Its Impact on Time to Steady State for Oral MeltDose Tacrolimus (LCPT) in De Novo Kidney Transplant Recipients (2025) · cites this paper as [13]
Half-life estimates may be influenced by the sampling duration.
“Half-life estimates may be influenced by the sampling duration.13,14”
From Evaluation of Effective Half-Life and Its Impact on Time to Steady State for Oral MeltDose Tacrolimus (LCPT) in De Novo Kidney Transplant Recipients (2025) · cites this paper as [13]
Calculations based on shorter intervals may provide different estimates of terminal half-life (t1/2z) compared with studies with longer sampling windows.
“Calculations based on shorter intervals may provide different estimates of t1/2z compared with studies with longer sampling windows.13,14”
From Evaluation of Effective Half-Life and Its Impact on Time to Steady State for Oral MeltDose Tacrolimus (LCPT) in De Novo Kidney Transplant Recipients (2025) · cites this paper as [13]
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- Authors
- Trofe-Clark, J., Brennan, D. C., West-Thielke, P., Milone, M. C., Lim, M. A., Neubauer, R., Nigro, V., & Bloom, R. D.
- Affiliations
- Washington University in St. Louis (US)
- University of Pennsylvania (US)
- Veloxis Pharmaceuticals, Inc. (United States) (US)
- Corresponding author
- Bloom, Roy D.
- Venue
- American Journal of Kidney Diseases
- Publisher
- Elsevier BV
- Published
- 2018-03
- Volume
- 71
- Issue
- 3
- Pages
- 315-326
- ISSN
- 0272-6386 (ISSN-L)
- OpenAlex
- W2770766047
- Cited by
- 93
- References
- 61
- Citations by year
- 2026: 9 · 2025: 11 · 2024: 11 · 2023: 15 · 2022: 8 · 2021: 11 · 2020: 12 · 2019: 9 · 2018: 5 · 2017: 1
- FWCI
- 6.25
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- American Journal of Kidney Diseases (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Digital Commons@Becker (Washington University School of Medicine) (submittedVersion, cc-by-nc-nd)
- Archivio Istituzionale della Ricerca - Università degli Studi della Campania "Luigi Vanvitelli" (submittedVersion)
- Topics
- Health Sciences › Medicine › Transplantation › Renal Transplantation Outcomes and Treatments
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
- Health Sciences › Medicine › Surgery › Transplantation: Methods and Outcomes
- Keywords
- tacrolimus, CYP3A5 polymorphism, extended-release tacrolimus, immediate-release tacrolimus, pharmacogenetics, tacrolimus pharmacokinetics, bioavailability, immunosuppression dosing, trough concentration, peak concentration
- MeSH terms
- Adult, Black or African American, Delayed-Action Preparations, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Graft Rejection, Graft Survival, Humans, Immunosuppressive Agents, Male, Middle Aged, Pharmacogenetics, Postoperative Care, Prognosis, Prospective Studies, Kidney Transplantation, Tacrolimus, Treatment Outcome, Risk Assessment, Cross-Over Studies, Area Under Curve, Cytochrome P-450 CYP3A, Molecular Targeted Therapy
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