Study of Tacrolimus Melt-Dose® for Lung Transplant Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChiesi España, S.A.U.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
To evaluate the most relevant pharmacokinetic parameters of tacrolimus metabolism and their relationship with clinical effectiveness and safety .
Cmin Tacrolimus dose
Time frame
1 year of follow upSecondary outcomes
1
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
Time frame
1 year2
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.
Time frame
1 year3
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.
Time frame
1 year4
To assess renal function (glomerular flow rate).
glomerular and flow rate
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Chiesi España, S.A.U.
Lead sponsor
Trialance SCCL
Collaborator
Source ClinicalTrials.gov