Status:
TERMINATED
Twice Daily Versus Once Daily Administration of the Tacrolimus in Lung Transplantation
Lead Sponsor:
Hannover Medical School
Conditions:
Lung Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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.
Detailed Description
Prevalence data of non-compliance in solid organ transplantations fluctuate is reported in up to 39% of transplant recipients (z. B. for lung transplantations 13 - 22%; Kugler et al.). Non-compliance ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00930241
Start Date
July 1 2009
End Date
July 1 2012
Last Update
August 22 2018
Active Locations (3)
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1
Department of Respiratory Medicine, Medizinische Hochschule Hannover
Hanover, Germany, 30625
2
Hannover Medical School, Dept. of Respiratory Medicine
Hanover, Germany, 30625
3
Hannover Medical School
Hanover, Germany, 30625