Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT07042035
Status:
RECRUITING
Last Update Posted:
2025-06-27
First Post:
2025-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Tacrolimus Melt-Dose® for Lung Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2025-04-30', 'studyFirstSubmitQcDate': '2025-06-25', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the most relevant pharmacokinetic parameters of tacrolimus metabolism and their relationship with clinical effectiveness and safety .', 'timeFrame': '1 year of follow up', 'description': 'Cmin Tacrolimus dose'}], 'secondaryOutcomes': [{'measure': 'To assess the pharmacokinetic parameters of LCPT ( concentration/dose ratio (C/D)).', 'timeFrame': '1 year', 'description': 'Tacrolimus Cmin Tacrolimus dose Inter-patient tacrolimus variability. multiple measurements will be aggregated'}, {'measure': 'To assess clinical effectiveness (acute rejection).', 'timeFrame': '1 year', 'description': '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.'}, {'measure': 'To assess lung function (spirometry).', 'timeFrame': '1 year', 'description': 'Spirometry: Forced Vital Capacity (FVC) ml, percent of Forced Expiratory Volume in the first second (FEV1), and FEV1/FVC ratio.'}, {'measure': 'To assess renal function (glomerular flow rate).', 'timeFrame': '1 year', 'description': 'glomerular and flow rate'}, {'measure': 'To assess the most frequent complications in lung transplant.', 'timeFrame': '1 year', 'description': 'Assessment of immune activity indicators Patients with de novo Donor-Specific Antibody (dnDSA) detected after transplant - has or does not have (yes or no).'}, {'measure': 'To assess adverse events.', 'timeFrame': '1 year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Trasplant', 'Lung Transplantation']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients ≥18 years old.\n* Patients who have received a first unilateral or bilateral lung transplant.\n* Patients who have started oral treatment with tacrolimus using the LCPT formulation, with a once-daily dosage within the first 3 months post-transplant.\n* Patients with a treatment duration expected to be ≥12 months.\n* The patient (or their representative) can sign the informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients who have received a multi-organ transplant or have a history of any organ transplant, including lung.\n* Patients with an estimated survival of \\<12 months\n* Patients diagnosed with cystic fibrosis\n* Patients diagnosed with scleroderma.\n* Patients diagnosed with a systemic disease affecting the digestive system.\n* 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.\n* Patients who are participating or have participated in an interventional research study within 30 days prior to inclusion.\n* Pregnant women, those planning to become pregnant, or those who are breastfeeding.\n* Patients who are unable to complete the study.\n* Patients who have not signed the informed consent."}, 'identificationModule': {'nctId': 'NCT07042035', 'acronym': 'ESENCIAL', 'briefTitle': 'Study of Tacrolimus Melt-Dose® for Lung Transplant Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chiesi España, S.A.U.'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'CHI-TAC-2024-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '08908', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Peral Rodríguez', 'role': 'CONTACT', 'email': 'm.peral@chiesi.com', 'phone': '+34 663020512'}], 'facility': 'Chiesi España, Torre Realia BCN Plaza Europa 41-43', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '28041', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alicia de Pablo de Pablo, MhD', 'role': 'CONTACT', 'email': 'alic1575@separ.es'}, {'name': 'Alicia de Pablo de Pablo, MhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Peral Roddriguez', 'role': 'CONTACT', 'email': 'm.peral@chiesi.com', 'phone': '+34 663 0205 12'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiesi España, S.A.U.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Trialance SCCL', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}