Phase 4 N=36 Prevention

Dosing Strategies for de Novo Once-daily Extended Release Tacrolimus (LCPT) in Kidney Transplant Recipients

Kidney Transplant

Bottom Line

View on ClinicalTrials.gov: NCT03713645 ↗

Enrolled (actual)

Serious AEs

2.8%

Results posted

May 2023

Primary outcome: Primary: Time to First Therapeutic Tacrolimus Trough Concentration From Initiation of Tacrolimus Extended Release Measured in Days — 4.5; 6; 13.5 days

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Tacrolimus Extended Release Oral Tablet [Envarsus] 0.13mg/kg/day initiated within post-operative day 3 after kidney transplant (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Temple University
Primary completion: May 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to First Therapeutic Tacrolimus Trough Concentration From Initiation of Tacrolimus Extended Release Measured in Days	4.5; 6; 13.5	—
SECONDARY Average Estimated Glomerular Filtration Rate Within 30 Days	40; 46; 31.5	—
SECONDARY Number of Participants With no Impact of Tremor on Quality of Life	35	—
SECONDARY Weight-based Tacrolimus Dose During Study Period	0.128; 0.136; 0.176	—
SECONDARY Tacrolimus Dose During Study Period	9.6; 12.5; 13.8	—
SECONDARY Tacrolimus Trough Level During Study Period	10.78; 9.18; 7.98	—
SECONDARY Weight Based Tacrolimus Dose at Therapeutic Concentration	0.13; 0.20; 0.19	—
SECONDARY Tacrolimus Dose at Therapeutic Tacrolimus Concentration	12; 16; 16	—

Summary

Outcomes after kidney transplantation have been significantly enhanced with the advances made in immunosuppressive therapies. Tacrolimus is currently marketed as an extended-release once-daily formulation dosing option for patients, decreasing pill burden and possibly decreasing adverse effects. Some transplant recipients have been shown to have higher dosage requirements. According to the literature, this can be linked to genetic disparities in the metabolism of tacrolimus.. This potential complication, where differences on specific genes alters metabolism of tacrolimus, can increase difficulty in getting to a therapeutic drug level for immunosuppresants and is one large factor that contributes to the fact that kidney transplant survival rates differ between patients. Due to the enhanced bioavailability of Meltdose formulation once-daily extended-release tacrolimus, its de novo use in recent research and practice has been shown to expedite achievement of target tacrolimus trough concentrations. De novo use of once-daily tacrolimus formulations is understudied. Through a prospective investigational study, we aim to determine the optimal strategy for de novo dosing of once-daily extended release tacrolimus (MeltDose formulation) for kidney transplant recipients at Temple University Hospital.

Eligibility Criteria

Inclusion Criteria

Adult patient who is 18 years of age or older receiving a kidney transplant at the Temple University Hospital's Kidney Transplant Program who are capable of understanding consent and volunteer to take part in the study

Exclusion Criteria

Scheduled for multiple organ transplant at enrollment Non-English speaking Pregnant women Moderate-severe hepatic impairment (Child Pugh > 10 or bilirubin > 2) Existing contraindications to tacrolimus-based products including known hypersensitivity to tacrolimus or any other component of the formulation Receiving concomitant medications known to have strong drug-drug interaction potential with tacrolimus including fluconazole, voriconazole, posaconazole, isavuconazole, itraconazole, ketoconazole, diltiazem, verapamil, metronidazole, erythromycin, clarithromycin, rifampin, rifabutin, rifapentine, phenytoin, fosphenytoin, phenobarbital, primidone, carbamazepine, St. John's Wort, efavirenz, neivrapine, etravirine, atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, ritonavir, nelfinavir, saquinavir, tipranavir, cobicistat

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03713645). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.