Study of Tacrolimus Melt-Dose® for Lung Transplant Patients

N/ARecruitingNCT07042035

Chiesi España, S.A.U.240 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

240

Conditions

Lung Trasplant Lung Transplantation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Chiesi España, Torre Realia BCN Plaza Europa 41-43

L'Hospitalet de Llobregat, Barcelona, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Spain

RECRUITING

Outcomes

Primary Outcomes

To evaluate the most relevant pharmacokinetic parameters of tacrolimus metabolism and their relationship with clinical effectiveness and safety .

Cmin Tacrolimus dose

Time frame: 1 year of follow up

Secondary Outcomes

To assess the pharmacokinetic parameters of LCPT ( concentration/dose ratio (C/D)).

Tacrolimus Cmin Tacrolimus dose Inter-patient tacrolimus variability. multiple measurements will be aggregated

Time frame: 1 year

To assess clinical effectiveness (acute rejection).

multiple measurements will be aggregated: Humoral rejection (circulating antibodies: number of patients and number of episodes) Acute clinical rejection (ACR); number of patients and number of episodesChronic Lung Allograft Dysfunction (CLAD); number of patients.

Time frame: 1 year

To assess lung function (spirometry).

Spirometry: Forced Vital Capacity (FVC) ml, percent of Forced Expiratory Volume in the first second (FEV1), and FEV1/FVC ratio.

Time frame: 1 year

To assess renal function (glomerular flow rate).

glomerular and flow rate

Time frame: 1 year

To assess the most frequent complications in lung transplant.

Assessment of immune activity indicators Patients with de novo Donor-Specific Antibody (dnDSA) detected after transplant - has or does not have (yes or no).

Time frame: 1 year

To assess adverse events.

Adverse Events (AEs), Adverse Drug Reactions (ADRs). AEs of special interest \[assessed in case report form (CRF) on a case-by-case basis\]: thrombotic microangiopathy (incidence after transplant); Reversible posterior encephalopathy (incidence after transplant); Pulmonary thromboembolism.

Central Contacts

Peral Roddriguez

CONTACT

+34 663 0205 12 m.peral@chiesi.com

Data from ClinicalTrials.gov

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