Study of Tacrolimus Melt-Dose® for Lung Transplant Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-29

Study Completion Date

2026-12-31

Brief Summary

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To evaluate, under usual clinical practice conditions and with a 12-month follow-up , the most relevant pharmacokinetic parameters of tacrolimus metabolism and safety, in patients with recent lung transplant (unilateral or bilateral) treated with LCPT.

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Detailed Description

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Conditions

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Lung Trasplant Lung Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients ≥18 years old.
* Patients who have received a first unilateral or bilateral lung transplant.
* Patients who have started oral treatment with tacrolimus using the LCPT formulation, with a once-daily dosage within the first 3 months post-transplant.
* Patients with a treatment duration expected to be ≥12 months.
* The patient (or their representative) can sign the informed consent to participate in the study.

Exclusion Criteria

* Patients who have received a multi-organ transplant or have a history of any organ transplant, including lung.
* Patients with an estimated survival of \<12 months
* Patients diagnosed with cystic fibrosis
* Patients diagnosed with scleroderma.
* Patients diagnosed with a systemic disease affecting the digestive system.
* Patients in any situation or condition that, in the investigator's opinion, makes participation inadvisable, such as any treatment that may interfere with the study.
* Patients who are participating or have participated in an interventional research study within 30 days prior to inclusion.
* Pregnant women, those planning to become pregnant, or those who are breastfeeding.
* Patients who are unable to complete the study.
* Patients who have not signed the informed consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No