Prospective randomized trial to compare a twice daily to a once daily administration of the Tacrolimus in lung transplanted patients - Advagraf-Study

• Conditions: Patients ( =18 and = 70 years) = 1 year after single, double or heart/lung transplantation.

• Registration Number: EUCTR2009-011324-60-DE
• Lead Sponsor: Hannover Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-13
• Last Update Posted: 24 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

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 (< 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)

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

• 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.

Study & Design

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