Lung Transplantation Clinical Trial
Official title:
Prospective Randomized Trial to Compare a Twice Daily to a Once Daily Administration of the Tacrolimus in Lung Transplanted Patients
NCT number | NCT00930241 |
Other study ID # | 5281M mono |
Secondary ID | |
Status | Terminated |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | July 2009 |
Est. completion date | July 2012 |
Verified date | August 2018 |
Source | Hannover Medical School |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is a prospective randomized trial to compare twice daily to once daily administration of the basic immunosuppressive regimen in lung transplanted patients.
Status | Terminated |
Enrollment | 25 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Respiratory Medicine, Medizinische Hochschule Hannover | Hannover | |
Germany | Hannover Medical School | Hannover | |
Germany | Hannover Medical School, Dept. of Respiratory Medicine | Hannover |
Lead Sponsor | Collaborator |
---|---|
Hannover Medical School |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 6 months | ||
Secondary | Deterioration of graft function (FEV1) before and at month 12 after conversion | 6 months | ||
Secondary | Number of drug holidays (intake of less than 50% of prescribed doses in 24 hours) measured electronically | 6 months |
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