Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Trialance SCCL | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the most relevant pharmacokinetic parameters of tacrolimus metabolism and their relationship with clinical effectiveness and safety . | Cmin Tacrolimus dose | 1 year of follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| To assess clinical effectiveness (acute rejection). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peral Roddriguez | Contact | +34 663 0205 12 | m.peral@chiesi.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiesi España, Torre Realia BCN Plaza Europa 41-43 | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| 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. | 1 year |
| To assess renal function (glomerular flow rate). | glomerular and flow rate | 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). | 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. | 1 year |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
|