OBJECTIVES
Primary:
To evaluate efficacy of treatment with anakinra in subjects with CF who are ≥ 12 years of age by means of lung clearance index (LCI).
Secondary To evaluate safety and tolerability of treatment with anakinra as well as to investigate further effects of anakinra on lung function and quality of life (QOL) in subjects with CF.
Age ≥ 18 years (1st cohort). If justified by interim analysis, 18 > age ≥ 12 years (2nd cohort),
Informed consent of the patient (if applicable) and/or all legal guardians,
Sufficient fluency of patient and/or his/her representative in German language to comply with study-specific procedures (e.g. to complete required quality of life questionnaires),
sweat chloride ≥ 60mEq/L,
Expected non-compliance, i.e. inability or unwillingness to comply with study-specific procedures,
Known allergy to anakinra or any ingredient of the pharmaceutical formulation of Kineret®,
Planned immunization with attenuated (live) vaccine(s) during the treatment with the IMP or completed immunization with attenuated (live) vaccine(s) within 4 weeks prior to the first administration of the IMP,
Renal failure (creatinine in serum above ULN),
Crossover
Anakinra
DrugApplication of Anakinra once daily for 28 days
Absolute pre-post change of the lung clearance index (LCI)
Click on the lead sponsor to view all of their trials.
