Lung TrasplantESENCIALNCT07042035
Study of Tacrolimus Melt-Dose® for Lung Transplant Patients
An observational study of Lung Trasplant and Lung Transplantation, run by Chiesi España, S.A.U. at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Trasplant, Lung Transplantation
- How many people
- 240 participants
- Where
- 2 sitesSpain
- Study dates
- 29 Oct 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Chiesi España, Torre Realia BCN Plaza Europa 41-43
L'Hospitalet de Llobregat, Barcelona, 08908
Peral Rodríguez, +34 663020512, m.peral@chiesi.com
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Alicia de Pablo de Pablo, MhD, alic1575@separ.es
Alicia de Pablo de Pablo, MhD
About this study
Official 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.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the most relevant pharmacokinetic parameters of tacrolimus metabolism and their relationship with clinical effectiveness and safety .
Cmin Tacrolimus dose
Measured: 1 year of follow up
Secondary outcomes (6)
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
Measured: 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.
Measured: 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.
Measured: 1 year
To assess renal function (glomerular flow rate).
glomerular and flow rate
Measured: 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).
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start29 Oct 2024
- Primary completion29 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TrasplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi España, S.A.U.
- Sponsor type
- University, hospital or other
- Collaborators
- Trialance SCCL
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042035
- Sponsor's protocol ID
- CHI-TAC-2024-01
- Acronym
- ESENCIAL
- Status last verified
- Jun 2025
- First submitted
- 30 Apr 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07042035
- Acronym / sponsor ID
- ESENCIAL / CHI-TAC-2024-01
- Conditions
- Lung Trasplant, Lung Transplantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Chiesi España, S.A.U.University, hospital or other
- Collaborators
- Trialance SCCL
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 29 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
To assess the pharmacokinetic parameters of LCPT ( concentration/dose ratio (C/D)).
Time frame: 1 year
To assess clinical effectiveness (acute rejection).
Time frame: 1 year
To assess lung function (spirometry).
Time frame: 1 year
To assess renal function (glomerular flow rate).
Time frame: 1 year
To assess the most frequent complications in lung transplant.
Time frame: 1 year
To assess adverse events.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Trasplant and Lung Transplantation, run by Chiesi España, S.A.U. at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peral Roddriguez (+34 663 0205 12, m.peral@chiesi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.