Actively Recruiting
A Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With CF
Led by Heidelberg University · Updated on 2025-03-27
52
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With CF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older for the first cohort; if justified, ages 12 to under 18 for the second cohort
- Patient or legal guardian has given informed consent
- Sufficient fluency in German to complete study procedures and questionnaires
- Confirmed cystic fibrosis diagnosis by sweat chloride ≥ 60 mEq/L, or two CF-causing mutations in the CFTR gene, or typical nasal/rectal potential difference alterations
- Lung function FEV1 ≥ 50% predicted at screening
- Lung clearance index (LCI2.5) ≥ 7.05 at screening
- Ability to perform reproducible multiple breath washout and spirometry
- Oxygen saturation ≥ 90% on room air at screening
- No changes in cystic fibrosis lung disease medication for at least 4 weeks before first study drug administration; wash-out period may be extended up to 12 weeks if needed
- Adequate bone marrow function (neutrophils >1.5 x 10^9/L, platelets >100 x 10^9/L, hemoglobin >9.0 g/dL)
- Adequate liver function (GGT, ASAT, ALAT less than 3 times upper limit of normal)
- Adequate blood clotting (aPTT <39 seconds, INR <1.2)
- Negative HIV, hepatitis B and C serology, and negative Interferon-gamma release assay
- Negative pregnancy test for women of childbearing potential
- Use of adequate contraception for sexually active female participants
You will not qualify if you...
- Expected inability or unwillingness to comply with study procedures
- Known allergy to Anakinra or any ingredients in Kineret4
- Planned or recent (within 4 weeks) immunization with live attenuated vaccines
- Renal failure (serum creatinine above normal limit)
- History of tuberculosis or repeated detection of non-tuberculous mycobacteria in the last 12 months
- History of Burkholderia cenocepacia infection in the last 12 months
- Colonization with multi-resistant Staphylococcus aureus or multi-resistant gram-negative Pseudomonas aeruginosa if judged high risk by physician
- Acute lung exacerbation within 14 days before screening or treatment start
- Signs of other active infection within 14 days before screening or treatment start
- Immunosuppressive treatment or Anakinra use in the last 3 months
- Participation in another interventional trial within 30 days before screening
- Current use of oral corticosteroids
- Current oxygen supplementation
- Current treatment with etanercept
- History of lung transplantation
- Pregnant or nursing females
- Known hypersensitivity to hypertonic saline used for sputum induction
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University Children's Hospital Heidelberg, Cystic Fibrosis Centre
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
2
Universitätsmedizin Essen, Ruhrlandklinik
Essen, North Rhine-Westphalia, Germany, 45239
Actively Recruiting
3
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany, 13353
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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