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

NCT04944979 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-15

No results posted yet for this 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).

Conditions

  • Primary Immunodeficiency Disease

Interventions

BIOLOGICAL

Kedrion IVIG 10%

Kedrion intravenous immunoglobulin (IVIg) 10%

Sponsors & Collaborators

  • Kedrion S.p.A.

    lead INDUSTRY

Principal Investigators

  • Chiara Azzari · Azienda Ospedaliero-Universitaria Ospedale Pediatrico Meyer - Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2026-04-30
Completion
2026-10-30
FDA Drug
Yes

Countries

  • United States
  • Hungary
  • Italy
  • Portugal
  • Russia
  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04944979 on ClinicalTrials.gov