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A Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With CF (ANAKIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03925194
Recruitment Status : Not yet recruiting
First Posted : April 24, 2019
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Mirjam Stahl, Heidelberg University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis, 10011762 Drug: Anakinra Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase IIa, Randomized, Placebo-controlled, Double-blind, Cross-over Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With Cystic Fibrosis
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022


Arm Intervention/treatment
Experimental: Anakinra Drug: Anakinra
Application of Anakinra once daily for 28 days

Placebo Comparator: Placebo Drug: Anakinra
Application of Anakinra once daily for 28 days




Primary Outcome Measures :
  1. Absolute pre-post change of the lung clearance index (LCI) [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years (1st cohort). If justified by interim analysis, 18 > age ≥ 12 years (2nd cohort),
  2. Informed consent of the patient (if applicable) and/or all legal guardians,
  3. 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),
  4. Confirmed diagnosis of cystic fibrosis, fulfilling at least one of the following three criteria:

    1. sweat chloride ≥ 60mEq/L,
    2. two CF causing mutations in the CFTR gene,
    3. alterations of transepithelial potential difference of nasal or rectal epithelia typical for CF,
  5. Best FEV1 ≥ 70 % pred. in the last 12 months prior to screening,
  6. FEV1 ≥ 60 % pred. at screening,
  7. LCI ≥ 7.5 at screening,
  8. Ability to perform reproducible multiple breath washout and spirometry,
  9. Oxyhaemoglobin saturation of ≥ 90% on room air at screening,
  10. No changes in the medication for cystic fibrosis lung disease for at least 4 weeks prior to the first administration of the IMP of each treatment period (in case of medication changes in Period 1 the wash-out may be extended for up to 12 weeks in order to fulfill this criterion),
  11. Adequate bone marrow function assessed on the basis of: neutrophils >1.5 x 109/L, platelets >100 x 109/L, hemoglobin >9.0 g/dL,
  12. Adequate liver function assessed on the basis of: GGT, ASAT, and ALAT <3 x ULN,
  13. Adequate blood clotting assessed on the basis of: aPTT <39 sec., INR <1.2,
  14. Negative serology for HIV (anti-HIV 1/2 IgG/IgM and p24-Ag), HBV (anti-HBs quantitative and anti-HBc IgG/IgM) and HCV (anti-HCV IgG), negative Interferon-gamma release assay,
  15. Negative Beta-HCG blood/urine test in women of childbearing potential (of childbearing potential are females who have experienced menarche and are not permanently sterile or postmenopausal (postmenopausal: 12 consecutive months with no menses without an alternative medical cause)),
  16. Use of adequate contraception in sexually active female subjects (sexual abstinence, hormonal contraceptives or intrauterine device).

Exclusion Criteria:

  1. Expected non-compliance, i.e. inability or unwillingness to comply with study-specific procedures,
  2. Known allergy to anakinra or any ingredient of the pharmaceutical formulation of Kineret®,
  3. 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,
  4. Renal failure (creatinine in serum above upper limit of normal (ULN)),
  5. History of tuberculosis or repeated detection of non-tuberculous mycobacteria from airway samples in the last 12 months before start of each treatment period,
  6. History of detection of Burkholderia species in the last 12 months before start of each treatment period,
  7. Current colonization with multi-resistant Staphylococcus aureus (MRSA) and/or 4-multi-resistant gram negative (MRGN) Pseudomonas aeruginosa at start of each treatment period,
  8. Acute bronchopulmonary exacerbation (defined by modified Fuchs criteria (see Appendix 1), modification includes all ways of application of an antibiotic (e.g., oral, i.v., inhaled)) within 14 days prior to the screening and before start of each treatment period,
  9. Signs of other active infection within 14 days prior to the screening and before start of each treatment period (clinical symptoms (e.g. burning sensation while urinating, skin, wound or dental infection) and/or fever and/or deterioration of infection-specific laboratory parameters beyond changes driven by the underlying disease),
  10. Immunosuppressive treatment due to organ transplantation, rheumatic or autoimmune diseases,
  11. Participation in another interventional trial within the last 30 days prior to screening,
  12. Current oral corticosteroid use,
  13. Current oxygen supplementation,
  14. Current treatment with etanercept,
  15. Medical history of lung transplantation,
  16. Pregnant or nursing females (females of childbearing potential must have a negative pregnancy test at Screening),
  17. Known hypersensitivity to hypertonic saline (used for induction of sputum).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925194


Locations
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Germany
University Children's Hospital Heidelberg, Cystic Fibrosis Centre
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Olaf Sommerburg, MD    +49 6221 56 5696    Olaf.Sommerburg@med.uni-heidelberg.de   
Contact: Mirjam Stahl, MD    +49 6221 56 37049    Mirjam.Stahl@med.uni-heidelberg.de   
Principal Investigator: Olaf Sommerburg, MD         
Sub-Investigator: Mirjam Stahl, MD         
Sponsors and Collaborators
Heidelberg University
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Responsible Party: Mirjam Stahl, Deputy of Principal Investigator (Olaf Sommerburg), Heidelberg University
ClinicalTrials.gov Identifier: NCT03925194    
Other Study ID Numbers: EudraCT No.: 2016-004786-80-A
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents