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

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.

Conditions

• Premature Infants
• Very Premature Infants
• Inflammation

Interventions

DRUG

Anakinra (Kineret®)

Standard care plus Anakinra for 21 days

Sponsors & Collaborators

• Monash University

  collaborator OTHER

• Hudson Institute of Medical Research

  collaborator UNKNOWN

• Liggins Institute

  collaborator OTHER

• Starship Children's Hospital of New Zealand

  collaborator UNKNOWN

• Monash Medical Centre

  lead OTHER

Principal Investigators

• Marcel F Nold, Prof · Monash Health/ Monash University/ Hudson Institute of Medical Research

• Claudia Nold, Prof · Hudson Institute of Medical Research

• Rod Hunt, Prof · Monash Health / Monash University

• Robert Galinsky, Dr · Hudson Institute of Medical Research

• Gergely Toldi, Dr · Starship Children's Hospital / Liggins Institute

• Carl Kirkpatrick, Prof · Monash University

• David Metz, Dr · Monash Health / Royal Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

24 Weeks

Max Age

29 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-27

Primary Completion

2026-06-30

Completion

2026-12-31

Countries

• Australia
• New Zealand

Study Locations