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NCT06697431: NIKITA
Non Inferiority KawasakI Trial With Anakinra
Phase 4 trial testing Anakinra in Kawasaki Disease in 38 participants. Not yet recruiting.
1 April 2026
Quick facts
| Lead sponsor | Meyer Children's Hospital IRCCS |
|---|---|
| Phase | Phase 4 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 38 |
| Start date | 1 April 2025 |
| Primary completion | 1 April 2026 |
| Estimated completion | 1 April 2027 |
Drugs / interventions tested
- Anakinra (ANAKINRA) — full drug profile →
- Intravenous Immunoglobulins, Human — full drug profile →
Conditions studied
- Kawasaki Disease — all drugs for Kawasaki Disease →
- Anakinra — all drugs for Anakinra →
Sponsor
Meyer Children's Hospital IRCCS
Who can join
Adults 1 Month to 16, any sex, with Kawasaki Disease or Anakinra. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicenter, open-label, randomized, controlled, interventional trial followed by a long-term observational extension period in patients with Kawasaki Disease (KD) to be treated eitherwith endovenous Immunoglobulins (IVIG-standard treatment) versus anakinra Aim of the study: to demonstrate that anakinra is non-inferior to IVIG in KD, in terms of fever control in the acute phase and development of coronary artery dilation/aneurisms (CAA) within one year from the onset.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06697431
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT05854251 — Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β · Phase 2 · completed
Other recruiting trials for Kawasaki Disease
Currently open trials in the same condition.
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Other Meyer Children's Hospital IRCCS trials
Trials by the same sponsor.
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- NCT07468461 — CACP: Study on Camptodactyly - Arthropathy - Coxa Vara - Pericarditis (CACP) Syndrome · recruiting
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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 NCT06697431 (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 Meyer Children's Hospital IRCCS
- Last refreshed: 21 November 2024
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/NCT06697431.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing