RecruitingPhase 2NCT07254000

Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants


Sponsor

Monash Medical Centre

Enrollment

24 participants

Start Date

Jun 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A phase 2 randomised, three-arm, parallel-group, dose-ranging trial to determine safety, efficacy and optimal dosing of intravenous anakinra in premature neonates, with subcutaneous pharmacokinetic sub-study.


Eligibility

Min Age: 24 WeeksMax Age: 29 Weeks

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Anakinra (Kineret®) for people with inflammation, premature infants, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 24 Weeks to 29 Weeks.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnakinra (Kineret®)

Standard care plus Anakinra for 21 days


Locations(2)

Monash Children's Hospital

Clayton, Victoria, Australia

Starship Children's Hospital

Grafton, Auckland, New Zealand

View Full Details on ClinicalTrials.gov

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NCT07254000


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