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

Study acronym: ANAKIN
StatusTerminated
PhasePhase 2
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Trial terminated Sponsor's reason: Funding issues
    • Final enrollment: 33 participants (planned 52)
    • Primary completion date changed from estimate of Dec 1, 2026 to Jun 30, 2025
    • Study completion date changed from estimate of Dec 1, 2026 to Jul 25, 2025
  2. Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 35 words
    • Site details revised at 3 of 3 sites
  3. Primary completion date: Dec 1, 2024 to Dec 1, 2026
    • Study completion date: Jun 1, 2025 to Dec 1, 2026
    • Site details revised at 1 of 3 sites
    v8
  4. Study sites: 2 to 3
    • Eligibility criteria expanded, about 21 words
    v7
  5. Trial status: Not Yet Recruiting to Recruitingv6 Show 4 more changesShow less
    • Start date changed from estimate of Aug 1, 2022 to Dec 1, 2022
    • Study sites: 1 to 2
    • Primary completion date: Aug 1, 2024 to Dec 1, 2024
    • Study completion date: Dec 1, 2024 to Jun 1, 2025
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Jul 1, 2022 to Aug 1, 2024
    • Start date: Oct 1, 2021 to Aug 1, 2022
    • Study completion date: Jul 1, 2022 to Dec 1, 2024
    v5
  2. Start date: Oct 1, 2020 to Oct 1, 2021v4
  3. Start date: Oct 1, 2019 to Oct 1, 2020v3
  4. Study title shortened, about 7 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03925194
Lead Sponsor Heidelberg University
Conditions
(from sponsor)		 Cystic Fibrosis, 10011762
Related terms Cystic Fibrosis
Enrollment 33 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov