RecruitingACTRN12622000664741

Conversion lung transplant patients from Prograf to Advagraf or Envarsus

Pharmacokinetic Study of Conversion Between 2 Formulations of Tacrolimus in Stable Lung Transplant Patients


Sponsor

University Hospital Motol

Enrollment

50 participants

Start Date

Jan 1, 2021

Study Type

Interventional

Conditions

Summary

30 days after lung transplantation patients with tacrolimus (Prograf) will be transfered randomisation to once daily tacrolimus (Advagraf, Envarsus) Which product will be better evaluated Advagraf or Envarsus


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 99 Yearss

Plain Language Summary

Simplified for easier understanding

After a lung transplant, recipients must take immunosuppressive medications for life to prevent the body from rejecting the new lung. One of the most important of these is tacrolimus, which is typically taken twice daily as Prograf. Taking medications twice daily can be inconvenient and easy to forget, and twice-daily regimens are associated with less consistent drug levels in the blood. Once-daily formulations of tacrolimus — Advagraf and Envarsus — may simplify the regimen and improve adherence. This study converts lung transplant recipients who are 30 days post-transplant from twice-daily Prograf to either Advagraf or Envarsus, both taken once daily. The study compares these two once-daily options to find out which maintains better and more stable blood levels of tacrolimus and is better tolerated. You may be eligible if you are at least 18 years old, are approximately 30 days after your lung transplant, and require ongoing tacrolimus therapy. People who refuse to participate are excluded.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

tacrolimus: dose administered 1 mg once daily the total duration of administration 3 years the mode of administration tablet prolonged release formulation (Advagraf, Envarsus)

tacrolimus: dose administered 1 mg once daily the total duration of administration 3 years the mode of administration tablet prolonged release formulation (Advagraf, Envarsus)


Locations(1)

Prague, Czech Republic

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ACTRN12622000664741