Study of Tacrolimus Melt-Dose® for Lung Transplant Patients

NCT07042035 | Recruiting

• 1 other identifier: CHI-TAC-2024-01
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Lung Trasplant; Lung Transplantation

Outcome Measures

Primary Outcomes (1)

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

  Cmin Tacrolimus dose

  1 year of follow up

Secondary Outcomes (6)

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

  1 year

• To assess clinical effectiveness (acute rejection).

  1 year

• To assess lung function (spirometry).

  1 year

• To assess renal function (glomerular flow rate).

  1 year

• To assess the most frequent complications in lung transplant.

  1 year

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients after a first unilateral or bilateral lung transplant start treatment with rapid-release tacrolimus every 12 hours (IR-Tac formulation) and, after achieving a stable dose and before 3 months, switch to once-daily LCPT tacrolimus. These treatments will have been prescribed by the investigator following usual clinical practice, with no relation to inclusion in this study.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Chiesi España, S.A.U.: lead
• Trialance SCCL: collaborator

Study Sites (2)

Chiesi España, Torre Realia BCN Plaza Europa 41-43

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Central Study Contacts

Peral Roddriguez

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: June 27, 2025
• Study Start: October 29, 2024
• Primary Completion (Estimated): October 29, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)