Anakinra (Kineret®): Standard care plus Anakinra for 21 days
Study 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
Sex
ALL
Min age
24 Weeks
Max age
29 Weeks
Healthy volunteers
No
Inclusion Criteria:
* Born between 24+0 and 28+6 weeks of gestation
Exclusion Criteria:
* Inability of the legal representatives to consent,
* Genetic syndromes,
* Severe cardiac anomalies,
* Substantial pre-/perinatal compromise,
* Congenital diaphragmatic hernia,
* Intrauterine stroke,
* Conditions that could confound trial results
* Imminent death or plan for comfort / palliative care
* Infants born outside the recruiting institutions
Primary outcome measure(s)
Population Pharmacokinetics (PopPK) Model of the Clearance of anakinra in extremely premature neonates from birth, during the 3-week treatment period. — From Baseline up to Day 21 Point Estimate of Population Total Clearance (CL) of anakinra will be reported.
Population Pharmacokinetics (PopPK) Model of the Volume of Distribution of anakinra in extremely premature neonates from birth, during the 3-week treatment period. — From Baseline up to Day 21 Point Estimate of Population Volume of Distribution (VD) of anakinra will be reported.
Population Pharmacokinetics (PopPK) Model of the Absorption of Population of subcutaneously administered anakinra in extremely premature neonates from birth, during the 3-week treatment period. — Day 14-21 Point Estimate of Population Absorption of subcutaneously administered anakinra will be reported.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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