Trial · NCT07254000
Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants
NCT07254000, Phase 2, Recruiting, Monash Medical Centre
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants. Trials, record NCT07254000. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07254000
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants
- NCT number
- NCT07254000
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 24 participants, estimated
- Lead sponsor
- Monash Medical Centre
- Conditions
- Premature Infants, Very Premature Infants, Inflammation
- Interventions
- Anakinra (Kineret®)
- First posted
- 2025-11-28
- Last updated
- 2025-11-28
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Population Pharmacokinetics (PopPK) Model of the Clearance of anakinra in extremely premature neonates from birth, during the 3-week treatment period. | From Baseline up to Day 21 | Point Estimate of Population Total Clearance (CL) of anakinra will be reported. |
| Primary | Population Pharmacokinetics (PopPK) Model of the Volume of Distribution of anakinra in extremely premature neonates from birth, during the 3-week treatment period. | From Baseline up to Day 21 | Point Estimate of Population Volume of Distribution (VD) of anakinra will be reported. |
| Primary | Population Pharmacokinetics (PopPK) Model of the Absorption of Population of subcutaneously administered anakinra in extremely premature neonates from birth, during the 3-week treatment period. | Day 14-21 | Point Estimate of Population Absorption of subcutaneously administered anakinra will be reported. |
| Secondary | Incidence of bronchopulmonary dysplasia | 4 months. | Early efficacy endpoints (exploratory): incidence of bronchopulmonary dysplasia, in comparison to contemporary unit and national statistics. |
| Secondary | Hammersmith infant neurological examination | 6 months | Early efficacy endpoint (exploratory): Hammersmith infant neurological examination; performed at 3-4 months of corrected age, in comparison to contemporary unit and national statistics. |
| Secondary | Incidence of intracranial/intraventricular haemorrhage and peri-ventricular leukomalacia. | 4 months | Early efficacy endpoint (exploratory): incidence of intracranial/intraventricular haemorrhage and peri-ventricular leukomalacia, in comparison to contemporary unit and national statistics. |
| Secondary | Safety of anakinra in extremely premature neonates. | 4 weeks | Safety of anakinra IV and SC in premature neonates, at 3 dosing levels, measured as incidence of safety endpoints in particular late-onset sepsis and necrotizing enterocolitis (compared with contemporary unit and national statistics) as well as neutropenia, thrombocytopenia, acute kidney injury, drug-induced liver injury (per Hy's Law). |
| Secondary | Individual Total Clearance (CL) of anakinra in extremely premature neonates. | From Baseline up to Day 21. | Average of individual model-derived estimates of CL will be reported. |
| Secondary | Individual Volume of Distribution (VD) of anakinra in extremely premature neonates. | Baseline to Day 21. | Average of individual model-derived estimates of VD will be reported. |
| Secondary | Individual Absorption Rate Constant (Ka) of subcutaneously administered anakinra in extremely premature neonates. | Day 14-21. | Average of individual model-derived estimates of Ka will be reported. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07254000
GET https://conductscience.org/api/trials/v1/NCT07254000/registered