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Anakinra for Preterm Infants Pilot

Primary Purpose

Prematurity; Extreme, Inflammation

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Anakinra
Sponsored by
Monash Medical Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prematurity; Extreme focused on measuring anakinra, IL-1Ra, bronchopulmonary dysplasia, diffuse white matter injury

Eligibility Criteria

24 Weeks - 28 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Monash HealthRecruiting
  • Starship Children's Hospital, Te Whatu Ora - Health New ZealandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anakinra

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 1, 2022
Last Updated
August 13, 2023
Sponsor
Monash Medical Centre
Collaborators
Monash University, Hudson Institute of Medical Research, Te Whatu Ora - Health New Zealand, University of Auckland, New Zealand
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1. Study Identification

Unique Protocol Identification Number
NCT05280340
Brief Title
Anakinra for Preterm Infants Pilot
Official Title
Advancing IL-1Ra to Prevent Inflammatory Disease in Preterm Infants - Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Monash Medical Centre
Collaborators
Monash University, Hudson Institute of Medical Research, Te Whatu Ora - Health New Zealand, University of Auckland, New Zealand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity; Extreme, Inflammation
Keywords
anakinra, IL-1Ra, bronchopulmonary dysplasia, diffuse white matter injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Dose escalation
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anakinra
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Anakinra
Other Intervention Name(s)
Kineret
Intervention Description
Anakinra will be given to enrolled infants starting in the first 24hrs of life for the first 3 weeks of life.
Primary Outcome Measure Information:
Title
Number of participants with treatment-related serious adverse reactions (suspected and unexpected)
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Plasma interleukin-1 receptor antagonist levels will be measured and reported in pg/mL for each participant conferred by treatment with anakinra
Description
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.
Time Frame
22 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Weeks
Maximum Age & Unit of Time
28 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcel Nold, Prof
Phone
+61385723936
Email
marcel.nold@monash.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elys Green, Dr
Phone
+61385723650
Email
elys.green@monashhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcel Nold, Prof
Organizational Affiliation
Monash University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claudia Nold, Prof
Organizational Affiliation
Hudson Institute of Medical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rod Hunt, Prof
Organizational Affiliation
Monash University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rob Galinsky, Dr
Organizational Affiliation
Hudson Institute of Medical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gergely Toldi, Dr
Organizational Affiliation
Starship Children's Hospital, Te Whatu Ora - Health New Zealand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecka Atkinson
Phone
+61385722713
Email
rebecka.atkinson@hudson.org.au
Facility Name
Starship Children's Hospital, Te Whatu Ora - Health New Zealand
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gergely Toldi, Dr
Phone
+64 2 1167 3952
Email
gergely.toldi@auckland.ac.nz

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36389766
Citation
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.
Results Reference
derived

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Anakinra for Preterm Infants Pilot

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