Anakinra for Preterm Infants Pilot

September 15, 2024 updated by: Monash Medical Centre

Advancing IL-1Ra to Prevent Inflammatory Disease in Preterm Infants - Pilot

Phase I/II study of anakinra to prevent the impact of perinatal inflammation in extremely premature infants.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

With improvements in antenatal and neonatal care over the last 20 years, now infants are born as early as 22 weeks gestation and survive to discharge from hospital. This increased survival comes with increased risk of long term issues such as cerebral palsy and chronic lung disease. There is strong evidence to show these risks are increased due to an underlying inflammatory process initiated around the time of premature birth. This study aims to prove the safety of treating infants born between 24-27+6 weeks gestation with Anakinra, a medication which is similar to an anti-inflammatory molecule the body makes itself called Interleukin 1 Receptor Antagonist (IL-1Ra). Anakinra acts to reduce the inflammatory response and is currently used in adults and children as young as 8 months to manage autoimmune inflammatory conditions. This study looks at the safety of giving Anakinra to babies born extremely premature, over the first 3 weeks of life. Once safety is established, the investigators will conduct a larger trial studying the efficacy of this treatment for reducing the risk of long-term complications caused by neonatal inflammation in extremely preterm infants.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Health
  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand, 1023
        • Starship Children's Hospital, Te Whatu Ora - Health New Zealand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 2 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Born at 24 to 27+6 weeks gestation

Exclusion Criteria:

  • Inability of the legal representatives to consent
  • Any disease or condition that the investigators judge could confound the trial results; these include, but are not limited to, genetic syndromes, severe cardiac abnormalities, substantial pre-/perinatal compromise (profound/severe hypoxia (SaO2 <80% for >3h), congenital diaphragmatic hernia, intrauterine stroke and others.
  • Imminent death

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anakinra

First 6 enrolled infants given 1.0mg/kg anakinra alternate daily IV for first 3 weeks of life.

Remaining 18 enrolled infants given 0.8mg/kg anakinra daily IV for the first 3 weeks of life, if infant is ≥ 26 weeks gestation.

If infant is < 26 weeks gestation, dosing of 1.0mg/kg anakinra alternate daily IV for the first 3 weeks of life, will continue (3 infants only).
Drug: Anakinra
Anakinra will be given to enrolled infants starting in the first 24hrs of life for the first 3 weeks of life.
Other Names:
  • Kineret

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related serious adverse reactions (suspected and unexpected)
Time Frame: 3 weeks
Monitoring of vital signs and documentation of any significant adverse effects, for the duration of treatment which is 3 weeks, such as cardiorespiratory deterioration requiring escalation of therapy (need to start or increase inotropic medication), need for cardiopulmonary resuscitation, incidence of sepsis and death within 15mins of infusion. Continuously collected physiological data will be summarised as area under the curve in 24h epochs. Serum creatinine will be monitored for incidence of acute kidney injury on days 3, 7 and 14. Liver function will be monitored for incidence of drug-induced liver injury on days 3, 7 and 14.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma interleukin-1 receptor antagonist levels will be measured and reported in pg/mL for each participant conferred by treatment with anakinra
Time Frame: 22 days
Blood will be taken prior to commencement of the trial medication, then at 6 & 12hr post-dose on days 1 and 22 and 12hr post dose on day 3, 7 and 14 and the IL-1Ra level recorded in pg/mL.
22 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monash Medical Centre

Collaborators

Monash University
University of Auckland, New Zealand
Hudson Institute of Medical Research
Te Whatu Ora - Health New Zealand

Investigators

  • Principal Investigator: Marcel Nold, Prof, Monash University
  • Principal Investigator: Claudia Nold, Prof, Hudson Institute of Medical Research
  • Principal Investigator: Rod Hunt, Prof, Monash University
  • Principal Investigator: Rob Galinsky, Dr, Hudson Institute of Medical Research
  • Principal Investigator: Gergely Toldi, Dr, Starship Children's Hospital, Te Whatu Ora - Health New Zealand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2022

Primary Completion (Actual)

March 21, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

February 1, 2022

First Submitted That Met QC Criteria

March 12, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 15, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RES 21-0000-681A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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