Patients ( =18 and = 70 years) = 1 year after single, double or heart/lung transplantation.
Conditions
Interventions
Trade Name: Advagraf
Product Name: Advagraf
Pharmaceutical Form: Capsule, hard
Sponsors
Hannover Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Pts more than1 year after single lung, double lung or heart/lung transplantation and • Pts treated with ciclosporin, steroids and MMF and • Pts =18 and = 70 years and • Pts with one oft he following • Pts with recurrent acute rejections (RAR) ? two or more acute rejections in 3 months (first 3 years post Tx, 6 months (>3 years post Tx) defined by • transbronchial biopsy >A1 (or A1 with clinical criteria below)nach ISHLT (B>1R) or • decline of FEV1 > 10 % baseline after exclusion of infection, airway complication, effusion etc. and improvement to steroid-pulse therapy (methylprednisolone 15 mg/kg for three days) = FEV1 improvement > 10% compared to the last measurement before AR treatment • Pts with steroid-resistant or ongoing acute rejections (OAR) defined by ? transbronchial biopsy >A1 (or A1 with clinical criteria above) at least 4 weeks following steroid-pulse therapy (methylprednisolone 15 mg/kg for three days) or ? no FEV1 improvement (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Pregnant or breast feeding women • Pts who are not using a double-barrier method of birth control • Pts with systemic infections • Pts with severe diarrhea, vomiting, active ulcer • Pts with severe liver disease or liver cirrhosis • Pts with m-Tor inhibitors • Pts with hypersensitivity to Tacrolimus, other macrolides or other tablet ingredients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to - Improvement of adherence as measured by Tacrolimus trough level below the target level and dispensing of less than 50% of the prescribed doses in the last three days measured electronically before this subtherapeutic drug monitoring;Secondary Objective: The secondary objectives of this study are: • Deterioration of graft function as defined as more than 20% decline in maximum FEV1 before and at month 12 after conversion • Number of drug holidays (intake of less than 50% of prescribed doses in 24 hours) measured electronically • Evaluation of renal function in pts converted from CyA to Tac in combination with MMF and steroids as assessed by serum creatinine, creatinine clearance (Cockgroft Gault), MDRD and Cystatin C before and at month 1, 3, 6 and 12 after conversion • Evaluation of cardiovascular risk factors (hypertension, hyperlipidaemia, hypertriglyceridemia, diabetes mellitus) • Incidence of CMV infections and other infections • Efficacy: Incidence of acute rejection episodes, graft and patient survival • Safety: Incidence of adverse events • Comparison of MPA-mini-AUC under Tacrolimus once and twice daily administration ;Primary end point(s): Patients of the once daily administration group of the immunsupressive medication will have a better compliance compared to the twice daily group (as measured by the endpoints variability and medication abstraction from the electronic devices) | — |
Countries
Germany
Outcome results
None listed