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NCT04944979: KIDCARES10
Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10)
Phase 3 trial testing Kedrion IVIG 10% in Primary Immunodeficiency Disease in 30 participants. Participants enrolled and being followed up; not accepting new ones.
30 April 2026
Quick facts
| Lead sponsor | Kedrion S.p.A. |
|---|---|
| Phase | Phase 3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 31 March 2021 |
| Primary completion | 30 April 2026 |
| Estimated completion | 30 October 2026 |
| Sites | 21 locations across Italy, Slovakia, Russia, Hungary, Portugal, United States |
Drugs / interventions tested
- Kedrion IVIG 10% — full drug profile →
Conditions studied
- Primary Immunodeficiency Disease — all drugs for Primary Immunodeficiency Disease →
Sponsor
Kedrion S.p.A. — full company profile →
Who can join
Adults 2 to 16, any sex, with Primary Immunodeficiency Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04944979
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Kedrion IVIG 10%
Trials testing the same drug.
- NCT03961009 — Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients · Phase 3 · completed
- NCT01581593 — Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID) · Phase 3 · completed
Other Kedrion S.p.A. trials
Trials by the same sponsor.
- NCT03961009 — Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients · Phase 3 · completed
- NCT01531803 — Safety Study of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients · Phase 4 · terminated
- NCT01554956 — Efficacy/Safety of Human Plasminogen Eye Drop in Ligneous Conjunctivitis Patients · Phase 2, PHASE3 · completed
- NCT01581593 — Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID) · Phase 3 · completed
- NCT04586062 — Sponsor Initiated Expanded Access Protocol, Intermediate-Size Patient Population · available
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04944979 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kedrion S.p.A.
- Last refreshed: 15 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04944979.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing