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NCT04944979 · ClinicalTrials.gov registry record · Phase 3
Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10)
A Phase 3 study of Primary Immunodeficiency Disease, sponsored by Kedrion S.p.A..
- Active
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
- 20
- Study locations
NCT04944979: Active Phase 3 study of Primary Immunodeficiency Disease, sponsored by Kedrion S.p.A..
NCT04944979 is a Phase 3 study of Primary Immunodeficiency Disease that is active but no longer recruiting, run by Kedrion S.p.A.. The registered enrollment target is 30 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04944979, a Phase 3 study of Primary Immunodeficiency Disease, is active but no longer recruiting, sponsored by Kedrion S.p.A..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
Incidence rate (i.e., the mean number of acute serious bacterial infections per patientyear) of acute serious bacterial infections (bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis) according to pre-specified criteria).
Conditions Studied
Interventions
- BIOLOGICAL Kedrion IVIG 10%
Study Locations (20)
Other
- Dél-Pesti Centrumkórház - Országos Hematológiai És Infektológiai Intézet - Budapest
- SST Spedali Civili di Brescia - Brescia
- Azienda Ospedaliero-Universitaria - Ospedale Pediatrico Meyer - Florence
- I.R.C.C.S. Istituto Giannina Gaslini - Genova
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinic - Milan
- Azienda Ospedaliera Universitaria "Federico II" - Naples
- Fondazione Policlinico Tor Vergata - Roma
- IRCCS Ospedale Pediatrico Bambino Gesù - Roma
- Centro Hospitalar Lisboa Central - Hospital Dona Estefânia - Lisbon
- Centro Hospitalar Universitário do Porto - Hospital Santo António - Porto
- Children's City Clinical Hospital No. 9 named after G.N. Speransky, Moscow City Health Department - Moscow
- Dmitry Rogachev National Medical Research Center for Pediatric Hematology, Oncology and Immunology - Moscow
Louisiana
- Velocity Clinical Research - MedPharmics - Lafayette - Lafayette
- Louisiana State University Shreveport - Shreveport
California
- Benioff Children's Hospital - Mission Bay - San Francisco
Colorado
- IMMUNOe Health and Research Centers - Centennial
Florida
- Johns Hopkins All Children's Hospital - St. Petersburg
North Carolina
- Duke Children's Hospital & Health Center - Durham
Ohio
- Asthma and Allergy Center - Toledo - Toledo
Oklahoma
- Vital Prospects Clinical Research Institute PC - Tulsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-03-31 |
| Est. Completion | 2026-10-30 |
| Phase | Phase 3 |
What the registry record for NCT04944979 still lists
NCT04944979 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Primary Immunodeficiency Disease appearing as the primary indexed condition, and to 1 intervention - of which Kedrion IVIG 10% is the first listed.
NCT04944979 names 20 study sites across 8 states, led by Other, Louisiana, California.
Frequently Asked Questions
What is clinical trial NCT04944979 about?
NCT04944979 is a clinical study titled "Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10)". 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).
What is the current status of trial NCT04944979?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2021-03-31. Estimated completion is 2026-10-30.
What conditions does trial NCT04944979 study?
This clinical trial studies the following conditions: Primary Immunodeficiency Disease.
What interventions are being tested in trial NCT04944979?
The interventions under investigation include: Kedrion IVIG 10% (BIOLOGICAL).
Who is sponsoring clinical trial NCT04944979?
This trial is sponsored by Kedrion S.p.A., which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04944979 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Louisiana, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04944979's enrollment target sits among peer trials
30 1918th of 2000 higher than 68 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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