Phase II, open, one-site, pilot Clinical trial for assessing the pharmacokinetic characteristics, safety and tolerability after conversion of the immuno-suppressive regimen with Advagraf® to Envarsus® in patients with stable pulmonary transplant.
- Conditions
- ung transplant stableMedDRA version: 18.1Level: HLGTClassification code 10038668Term: Respiratory and pulmonary investigations (excl blood gases)System Organ Class: 10022891 - InvestigationsTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2015-005519-34-ES
- Lead Sponsor
- Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>- Determinate the safety profile with Envarsus treatment<br>- 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 Outcome Measures
Name Time Method Secondary end point(s): - Incidence of acute rejection, by biopsy, during 6 months post-conversion<br>- Percentage of patients with adverse events related to the investigational product (Envarsus®) <br>- 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 <br>- during all trial<br>- 6 months post -conversion