Lung transplant stable MedDRA version: 18.1 Level: HLGT Classification code 10038668 Term: Respiratory and pulmonary investigations (excl blood gases) System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Envarsus®
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: TACROLIMUS
CAS Number: 104987-11-3
Concentration unit: mg milligram(s)
Concentration type: range
Concentration
Sponsors
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients between 18 and 65 years, both inclusive - Patients with pulmonary transplant at least 6 months before the inclusion - Patients with immuno-suppressive regimen with Advagraf and that continue with the treatment at least 4 more weeks - Patients in stable phase with tacrolimus blood concentration of 5-15 µg/L, determinated in 2 times separated at least for 6 days during the selection period. - Patients capable of understanding purpose and risks of the study, that have been informed and have given their informed consent for participating in the trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Patients with neoplasia or neoplasia history 5 years before except cell carcinoma or non-metastasic epidermoid treated satisfactory. - Patients diagnosed with cystic fibrosis - Patients with generalized infections that needs treatment. - Patients with severe diarrhea, vomits, active peptic ulcer or digestive disorders that could affect tracrolimus absorption. - Patients that Advagraf® o Envarsus® are contraindicated - Evidence of acute rejection in the 3 previous months before the inclusion - Diagnosed chronic rejection. - Liver cirrhosis histologically confirmed - Patients with unacceptable pulmonary function - GPT (ALT), GOT (AST) and total bilirubin ? 3 ULN - Blood creatinine ? 2 mg/dl - Patients with drug addition, psychiatric disorder or condition that according to the investigator's opinion could difficult the patient participation. - Patients participating o has participated in another investigational trial within 28 days before the selection visit. - Patients HIV positive - Childbearing women that do not use effective birth control methods - Pregnancy or breast-feeding - Not sign the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determinate and compare the tacrolimus pharmacokinetic profile in stable pulmonary transplant patients after the conversion 1:0.7 from Advagraf® to Envarsus®;Secondary Objective: - By a biopsy, assess the acute rejection incidence during 6 months post-conversion. - Determinate the safety profile with Envarsus treatment - Know the percentage of patients that show adverse event related to Envarus that causes hospitalization during 6 months post-conversion;Primary end point(s): AUC0-24 h, Cmax, Tmax, Cmin and the correlation between AUC0-24 h and Cmin on the systematic exposure of 2 exteneded-realase oral formulations on stable phase;Timepoint(s) of evaluation of this end point: At week 2 or 4 (depending where the pharmacokinetic is done) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Incidence of acute rejection, by biopsy, during 6 months post-conversion - Percentage of patients with adverse events related to the investigational product (Envarsus®) - Percentage of patients with adverse event related to Envarus that causes hospitalization during 6 months post-conversion;Timepoint(s) of evaluation of this end point: - 6 months post -conversion - during all trial - 6 months post -conversion | — |
Countries
Spain
Contacts
Public ContactServicio de Neumología
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
Outcome results
None listed