Anakinra for Preterm Infants Pilot

NCT05280340 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: RES 21-0000-681A
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Prematurity; Extreme; Inflammation

Keywords

anakinra; IL-1Ra; bronchopulmonary dysplasia; diffuse white matter injury

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  22 days

Study Arms (1)

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).

Drug: Anakinra

Interventions

Anakinra DRUG

Anakinra will be given to enrolled infants starting in the first 24hrs of life for the first 3 weeks of life.

Also known as: Kineret

Anakinra

Eligibility Criteria

• Age: 24 Weeks - 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Born at 24 to 27+6 weeks gestation

You may not qualify if:

• 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

Sponsors & Collaborators

• Monash Medical Centre: lead
• Monash University: collaborator
• Hudson Institute of Medical Research: collaborator
• Te Whatu Ora - Health New Zealand: collaborator
• University of Auckland, New Zealand: collaborator

Study Sites (2)

Monash Health

Clayton, Victoria, 3168, Australia

Location

Starship Children's Hospital, Te Whatu Ora - Health New Zealand

Grafton, Auckland, 1023, New Zealand

Location

Related Publications (1)

• 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.

  PMID: 36389766 DERIVED

MeSH Terms

Conditions

Premature Birth; Inflammation; Bronchopulmonary Dysplasia

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Dose escalation

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: March 15, 2022
• Study Start: February 15, 2022
• Primary Completion: March 21, 2024
• Study Completion: March 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); NZ (1)