Lung InjuryPhase 1NCT04848272
Inhibition of Plasma Kallikrein as a New Therapy for Lung Injury
A Phase 1 study testing Lanadelumab in people with Lung Injury, run by St Vincent's Institute of Medical Research at 1 site in Australia.
Trial summary
Phase 1 study investigating safety of lanadelumab administration to patients with lung injury Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Injury
- What is being tested?
- Lanadelumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Aug 2021to Dec 2024
- Phase
- Phase 1
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years admitted to the ICU with primary diagnosis of lung injury. The criteria for the diagnosis of lung injury include five principal elements: hypoxemia (blood oxygen saturation (PaO2) ≤92% when breathing ambient air, ratio of PaO2 to the fraction of inspired oxygen (FiO2) ≤300), diffuse pulmonary infiltrates on chest radiographs, decreased lung compliance, and the absence of congestive heart failure.
- Both males and females will be recruited in the proportion in which they are admitted to the ICU with lung injury.
- Arterial cannula in place as part of usual care for the measurement of blood gases.
- Patients may or may not be intubated and mechanically ventilated.
- Able to provide informed consent, or if unable to do so, a responsible person:
- medical treatment decision maker is available (by telephone if necessary) who can be approached to seek consent.
Who cannot join
- Other causes of lung infiltrates: pulmonary oedema, alveolar haemorrhage, adverse drug reactions, radiation injury and the idiopathic pneumonitis syndrome.
- Significant dysfunction of non-pulmonary organs in the opinion of the treating ICU consultant.
- Death is deemed imminent or inevitable or there is underlying disease with a life expectancy of less than 90 days.
- Previously enrolled in this study.
- Enrolled in another study.
- Usually receives home oxygen.
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- Usually receives any type of assisted ventilation at home. e.g. continuous positive airway pressure for obstructive sleep apnoea.
- Pregnant or might be pregnant. Women aged 18 to 49 are excluded unless there is documented menopause, hysterectomy or surgical sterilisation, or a pregnancy test is negative.
- Objection from the treating clinician.
- Consent refused by the patient or substitute decision maker.
Trial locations and contacts
1 site in 1 country.
About this study
Phase 1 study investigating safety of lanadelumab administration to patients with lung injury
Read the detailed description
This study will investigate the safety of inhibition of plasma kallikrein by lanadelumab administration in patients with lung injury.
- Conditions
- Lung Injury
- Being tested
- Lanadelumab, Saline control
- Medical subject headings
- Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LanadelumabDrug
Also called Takhzyro
Monoclonal antibody that targets active plasma kallikrein
Saline controlOther
Saline control
| Study group | Role | What they receive |
|---|---|---|
| Saline control | Placebo comparator | Saline control Receives: Other: Saline control |
| Lanadelumab 30 mg | Experimental | Lanadelumab 30 mg Receives: Drug: Lanadelumab |
| Lanadelumab 100 mg | Experimental | Lanadelumab 100 mg Receives: Drug: Lanadelumab |
| Lanadelumab 300 mg | Experimental | Lanadelumab 300 mg Receives: Drug: Lanadelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Related Adverse Events
Blood gases, pH, bicarbonate, carbon dioxide and lactic acid levels. If the participant is receiving mechanical ventilation, the ventilator settings will be constantly monitored.
Chest X-ray, as indicated. Constant monitoring of haemodynamics (pulse rate, blood pressure) via an arterial cannula, use of vasoactive medications, and constant monitoring of ECG. Fluid balance, including urine output. Serum creatinine, electrolytes, liver function, creatinine kinase, FBE and coagulation will be measured daily or less frequently as decided by the treating team.
If there is suspicion of infection, then appropriate samples will be taken for microbiological examination.
Neurological function will be assessed several times per day.
Measured: 28 days
Secondary outcomes (1)
Blood bradykinin concentration
Blood bradykinin concentration
Measured: 0, 6, 12, and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start9 Aug 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung InjuryStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Open-label placebo-controlled dose-escalation Phase 1 study
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Vincent's Institute of Medical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duncan Campbell, St Vincent's Institute of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848272
- Sponsor's protocol ID
- SVI-01
- Status last verified
- Apr 2024
- First submitted
- 13 Apr 2021
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised individual participant data (IPD) available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibition of Plasma Kallikrein as a New Therapy for Lung Injury
- ClinicalTrials.gov ID
- NCT04848272
- Acronym / sponsor ID
- SVI-01
- Conditions
- Lung Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- St Vincent's Institute of Medical ResearchUniversity, hospital or other
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Apr 2021 (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 1 study investigating safety of lanadelumab administration to patients with lung injury
Detailed description
This study will investigate the safety of inhibition of plasma kallikrein by lanadelumab administration in patients with lung injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Open-label placebo-controlled dose-escalation Phase 1 study
| Arm | Type | Receives |
|---|---|---|
| Saline control | Placebo comparator | Other: Saline controlSaline control |
| Lanadelumab 30 mg | Experimental | Drug: LanadelumabLanadelumab 30 mg |
| Lanadelumab 100 mg | Experimental | Drug: LanadelumabLanadelumab 100 mg |
| Lanadelumab 300 mg | Experimental | Drug: LanadelumabLanadelumab 300 mg |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >18 years admitted to the ICU with primary diagnosis of lung injury. The criteria for the diagnosis of lung injury include five principal elements: hypoxemia (blood oxygen saturation (PaO2) ≤92% when breathing ambient air, ratio of PaO2 to the fraction of inspired oxygen (FiO2) ≤300), diffuse pulmonary infiltrates on chest radiographs, decreased lung compliance, and the absence of congestive heart failure.
- Both males and females will be recruited in the proportion in which they are admitted to the ICU with lung injury.
- Arterial cannula in place as part of usual care for the measurement of blood gases.
- Patients may or may not be intubated and mechanically ventilated.
- Able to provide informed consent, or if unable to do so, a responsible person:
Key exclusion criteria (10 listed)
- Other causes of lung infiltrates: pulmonary oedema, alveolar haemorrhage, adverse drug reactions, radiation injury and the idiopathic pneumonitis syndrome.
- Significant dysfunction of non-pulmonary organs in the opinion of the treating ICU consultant.
- Death is deemed imminent or inevitable or there is underlying disease with a life expectancy of less than 90 days.
- Previously enrolled in this study.
- Enrolled in another study.
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 |
|---|---|---|
| LanadelumabAlso: TakhzyroMonoclonal antibody that targets active plasma kallikrein | Drug | Lanadelumab 100 mg, Lanadelumab 30 mg, Lanadelumab 300 mg |
| Saline controlSaline control | Other | Saline control |
Primary outcome
Number of Participants With Treatment-Related Adverse Events
Time frame: 28 days
Blood gases, pH, bicarbonate, carbon dioxide and lactic acid levels. If the participant is receiving mechanical ventilation, the ventilator settings will be constantly monitored. Chest X-ray, as indicated. Constant monitoring of haemodynamics (pulse rate, blood pressure) via an arterial cannula, use of vasoactive medications, and constant monitoring of ECG. Fluid balance, including urine output. Serum creatinine, electrolytes, liver function, creatinine kinase, FBE and coagulation will be measured daily or less frequently as decided by the treating team. If there is suspicion of infection, then appropriate samples will be taken for microbiological examination. Neurological function will be assessed several times per day.
1 secondary outcome
Blood bradykinin concentration
Time frame: 0, 6, 12, and 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: Yes. Anonymised individual participant data (IPD) available to other researchers
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lanadelumab in people with Lung Injury, run by St Vincent's Institute of Medical Research at 1 site in Australia.
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 6 inclusion and 10 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 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 Adverse Events (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2024.