Conversion from a twice-daily tacrolimus (tac) regimen to a once-daily tacorlimus exended-release formulation (TacXL) regimen : Pharamcokinetic studies in stable cystic fibrosis (CF) and non-CF patients having received a pulmonary transplant - Tac-X

• Conditions: Stable cystic fibrosis (CF) and non-CF patients having received a pulmonary transplant; MedDRA version: 12.0Level: LLTClassification code 10025127Term: Lung transplant

• Registration Number: EUCTR2009-014050-15-BE
• Lead Sponsor: Hopital Erasme - Chest service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-14
• Last Update Posted: 14 October 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- stable CF and non-CF patients having received a pulmonary transplant who did not represent an acute rejection during the 12 months before study entry
-patients who present with a normal or only moderate altered renal function (creatinine clearance > 50ml/dl)
- written informed consent
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- patients on medications known to interfere with Tac metabolism (ie. isoniazide, rifampicin, aticonvulsivants, azole anti-fungal agents).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To asses PK parameters for Tac-XL versus conventional Tac in stable CF and non-CF lung transplant patients.;Secondary Objective: To assess the intra-individual reproducibility of these PK data obtained with Tac-XL and Tac.<br><br>To asses safety in terms of graft function and side effects;Primary end point(s): - Asses PK parameters<br>- compare inter and intra-individual variability of the PK data achieved with the two formulations