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

• Status: Terminated
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a prospective randomized trial to compare twice daily to once daily administration of the basic immunosuppressive regimen in lung transplanted patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hannover Medical School
• Treatments: Tacrolimus

Criteria

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