Inhibition of Plasma Kallikrein as a New Therapy for Lung Injury

Lung Injury Clinical Trial

Official title:

Inhibition of Plasma Kallikrein as a New Therapy for Lung Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04848272
• Other study ID #: SVI-01
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: August 9, 2021
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: St Vincent's Institute of Medical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 1 study investigating safety of lanadelumab administration to patients with lung injury

Description:

This study will investigate the safety of inhibition of plasma kallikrein by lanadelumab administration in patients with lung injury.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Lung Injury
• Wounds and Injuries

Intervention

Drug:
• Lanadelumab
Monoclonal antibody that targets active plasma kallikrein

Other:
• Saline control
Saline control

Locations

Country	Name	City	State
Australia	St Vincent's Hospital Melbourne	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
St Vincent's Institute of Medical Research

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28 days
Secondary	Blood bradykinin concentration	Blood bradykinin concentration	0, 6, 12, and 24 hours