Prematurity; ExtremePhase 1/2NCT05280340
Anakinra for Preterm Infants Pilot
A Phase 1/2 study testing Anakinra in people with Prematurity; Extreme and Inflammation, run by Monash Medical Centre at 2 sites in 2 countries.
Trial summary
Phase I/II study of anakinra to prevent the impact of perinatal inflammation in extremely premature infants. Read more about this study
- Who is it for?
- Ages 24 to 28 weeks
- Conditions the study is for
- Prematurity; Extreme, Inflammation
- What is being tested?
- Anakinra
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Feb 2022to Mar 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 28 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born at 24 to 27+6 weeks gestation
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
New Zealand1 site
Starship Children's Hospital, Te Whatu Ora - Health New Zealand
Grafton, Auckland, 1023
About this study
Official title: 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.
Read the 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.
- Conditions
- Prematurity; Extreme, Inflammation
- Being tested
- Anakinra
- Keywords
- anakinra, IL-1Ra, bronchopulmonary dysplasia, diffuse white matter injury
- Medical subject headings
- Premature Birth, Inflammation, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnakinraDrug
Also called Kineret
Anakinra will be given to enrolled infants starting in the first 24hrs of life for the first 3 weeks of life.
| Study group | Role | What they receive |
|---|---|---|
| Anakinra | Experimental | 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). Receives: Drug: Anakinra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related serious adverse reactions (suspected and unexpected)
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.
Measured: 3 weeks
Secondary outcomes (1)
Plasma interleukin-1 receptor antagonist levels will be measured and reported in pg/mL for each participant conferred by treatment with anakinra
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.
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start15 Feb 2022
- Primary completion21 Mar 2024
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prematurity; ExtremeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dose escalation
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash Medical Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University, Hudson Institute of Medical Research, Te Whatu Ora - Health New Zealand, University of Auckland, New Zealand
- Responsible party
- Sponsor
- Investigators
- Marcel Nold, Prof, Principal investigator, Monash UniversityClaudia Nold, Prof, Principal investigator, Hudson Institute of Medical ResearchRod Hunt, Prof, Principal investigator, Monash UniversityRob Galinsky, Dr, Principal investigator, Hudson Institute of Medical ResearchGergely Toldi, Dr, Principal investigator, Starship Children's Hospital, Te Whatu Ora - Health New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280340
- Sponsor's protocol ID
- RES 21-0000-681A
- Status last verified
- Sep 2024
- First submitted
- 1 Feb 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Green EA, Metz D, Galinsky R, Atkinson R, Skuza EM, Clark M, Gunn AJ, Kirkpatrick CM, Hunt RW, Berger PJ, Nold-Petry CA, Nold MF. Anakinra Pilot - a clinical trial to demonstrate safety, feasibility and pharmacokinetics of interleukin 1 receptor antagonist in preterm infants. Front Immunol. 2022 Oct 27;13:1022104. doi: 10.3389/fimmu.2022.1022104. eCollection 2022.
PubMed 36389766
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing IL-1Ra to Prevent Inflammatory Disease in Preterm Infants - Pilot
- ClinicalTrials.gov ID
- NCT05280340
- Acronym / sponsor ID
- RES 21-0000-681A
- Conditions
- Prematurity; Extreme, Inflammation
- Keywords
- anakinra, IL-1Ra, bronchopulmonary dysplasia, diffuse white matter injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Monash Medical CentreUniversity, hospital or other
- Collaborators
- Monash University, Hudson Institute of Medical Research, Te Whatu Ora - Health New Zealand, University of Auckland, New Zealand
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- Mar 2025 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I/II study of anakinra to prevent the impact of perinatal inflammation in extremely premature infants.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation
| Arm | Type | Receives |
|---|---|---|
| Anakinra | Experimental | Drug: AnakinraFirst 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). |
Who may qualify
- Ages
- 24 to 28 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Born at 24 to 27+6 weeks gestation
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnakinraAlso: KineretAnakinra will be given to enrolled infants starting in the first 24hrs of life for the first 3 weeks of life. | Drug | Anakinra |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 36389766Green EA, Metz D, Galinsky R, Atkinson R, Skuza EM, Clark M, Gunn AJ, Kirkpatrick CM, Hunt RW, Berger PJ, Nold-Petry CA, Nold MF. Anakinra Pilot - a clinical trial to demonstrate safety, feasibility and pharmacokinetics of interleukin 1 receptor antagonist in preterm infants. Front Immunol. 2022 Oct 27;13:1022104. doi: 10.3389/fimmu.2022.1022104. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcel Nold, Prof principal investigator
Monash University
Claudia Nold, Prof principal investigator
Hudson Institute of Medical Research
Rod Hunt, Prof principal investigator
Monash University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Anakinra in people with Prematurity; Extreme and Inflammation, run by Monash Medical Centre at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related serious adverse reactions (suspected and unexpected) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05280340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 27 Oct 2026.