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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 3 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Monash Medical Centre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Monash University
University of Auckland, New Zealand
Hudson Institute of Medical Research
Te Whatu Ora - Health New Zealand

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 21, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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