Risk Factors That Increase the Chance of Developing Primary Graft Dysfunction After Lung Transplantation
NCT00552357
Cardiovascular Diseases, Lung Transplantation
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT Number: NCT07042035
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Chiesi España, Torre Realia BCN Plaza Europa 41-43, L'Hospitalet de Llobregat, Barcelona, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 year of follow up
Cmin Tacrolimus dose
Time frame: 1 year
Tacrolimus Cmin Tacrolimus dose Inter-patient tacrolimus variability. multiple measurements will be aggregated
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.
Time frame: 1 year
Spirometry: Forced Vital Capacity (FVC) ml, percent of Forced Expiratory Volume in the first second (FEV1), and FEV1/FVC ratio.
Time frame: 1 year
glomerular and flow rate
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).
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.
Contact information is provided by the study sponsor or research team.
Chiesi España, S.A.U.
Other
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
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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