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Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10)

Study acronym: KIDCARES10
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Apr 30, 2026 to Dec 2026
    • Study completion pushed from Oct 30, 2026 to May 2027
    v14
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 21 of 21 sites
    v13
  3. Site details revised at 1 of 21 sitesv12
  4. Site details revised at 1 of 21 sitesv11
  5. Study sites: 19 to 21v10
Show 8 earlier versionsHide 8 earlier versions
  1. Site details revised at 6 of 19 sitesv9
  2. Study sites: 20 to 19v8
  3. Secondary endpoints revised (45)v7
  4. Eligibility criteria shortened, about 82 wordsv6
  5. Primary completion date: Dec 31, 2023 to Apr 30, 2026
    • Study sites: 13 to 20
    • Study completion date: Jun 30, 2024 to Oct 30, 2026
    v5
  6. Re-verified, no change to tracked fieldsv4
  7. Study sites: 9 to 13v3
  8. Primary completion date: Dec 31, 2022 to Dec 31, 2023
    • Study completion date: Apr 30, 2023 to Jun 30, 2024
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Kedrion S.p.A.
6 trials monitored
See 1 trial at risk
The purpose of this study is to assess efficacy, safety and pharmacokinetics of Kedrion Immunoglobulin 10% (KIg10) in pediatric patients with Primary Immunodeficiency Disease (PID).
Trial Details
NCT Number NCT04944979
Lead Sponsor Kedrion S.p.A.
Conditions
(from sponsor)		 Primary Immunodeficiency Disease
Related terms Agammaglobulinemia, Primary Immunodeficiency Diseases
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov