Twice Daily Versus Once Daily Administration of the Tacrolimus in Lung Transplantation

Inclusion Criteria: * Patients (Pts) more than 1 year after single lung, double lung or heart/lung transplantation * Pts treated with cyclosporin, steroids and MMF * Pts ≥ 18 and ≤ 70 years and * Pts with one of the 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 (\< 5% baseline) at least 14 days following ACR steroid-pulse therapy (methylprednisolone 15 mg/kg for three days) after exclusion of infection, airway complication, effusion etc. or * Pts with new onset of BOS (nBOS) Unexplained FEV1 \< 80% of baseline after exclusion of Infection, airway complication, effusion etc * Pts with CyA associated side effects (e.g., hyperlipidaemia, hypertriglyceridemia, hypertension, hirsutism, gingival hyperplasia) 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