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NCT Number: NCT07042035

Study of Tacrolimus Melt-Dose® for Lung Transplant Patients

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chiesi España, Torre Realia BCN Plaza Europa 41-43, L'Hospitalet de Llobregat, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 1 year of follow up

    Cmin Tacrolimus dose

Secondary outcomes

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

    Time frame: 1 year

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

  2. To assess clinical effectiveness (acute rejection).

    Time frame: 1 year

    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.

  3. To assess lung function (spirometry).

    Time frame: 1 year

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

  4. To assess renal function (glomerular flow rate).

    Time frame: 1 year

    glomerular and flow rate

  5. To assess the most frequent complications in lung transplant.

    Time frame: 1 year

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

  6. To assess adverse events.

    Time frame: 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Peral Roddriguez

CONTACT

[email protected]

+34 663 0205 12

Sponsors and collaborators

Lead sponsor

Chiesi España, S.A.U.

Other

Collaborators

  • Trialance SCCL

Registry information

Official study title

Pharmacokinetic Study, Effectiveness, and Safety of the Tacrolimus Formulation Based on Melt-Dose® Technology (LCPT) as an Immunosuppressive Treatment for Lung Transplant Patients, Under Usual Clinical Practice Conditions.

Acronym: ESENCIAL

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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