Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374797
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-04-16
Brief Title:
A Study of Auxora in Patients with AKI and Injurious Lung Crosstalk
Sponsor:
CalciMedica Inc
Organization:
CalciMedica Inc
Study Overview
Official Title:
Auxora for the Treatment of AKI and Modulation of Injurious Crosstalk with the Lung a Randomized Control Trial KOURAGE
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KOURAGE
Brief Summary:
Approximately 150 patients with acute kidney injury AKI associated with acute hypoxemic respiratory failure AHRF will be randomized at up to 40 sites Patients will be randomly assigned to either Auxora or matching placebo Study drug infusions will occur every 24 hours for five consecutive days for a total of five infusions
Detailed Description:
This double blind randomized placebo-controlled study will evaluate the efficacy safety and tolerability of Auxora in patients with severe AKI who have associated AHRF The definition of AKI and the stages of AKI will be based on the classification system proposed by the Acute Kidney Injury Working Group of Kidney Disease Improving Global Outcomes KDIGO and incorporate both serum creatinine and urine volume criteria AHRF will be defined as a PF 300 that has been determined by either an arterial blood gas or imputed from the oxygen saturation SpO2 recorded using pulse oximetry and is being treated with high flow nasal cannula with minimum flow rate 30 litersmin or non-invasive mechanical ventilation or invasive mechanical ventilation Approximately 150 patients with severe AKI defined as having developed either stage 2 or 3 AKI at the time of consent who have associated AHRF will be randomized 11 into either the Auxora or placebo group using a computer-generated randomization scheme accessed through an interactive voiceweb response system IXRS Randomization will be stratified by the use of invasive mechanical ventilation and by Stage 3 AKI
Patients who are randomized to the Auxora group will receive 125 mLkg 20 mgkg of zegocractin IV over 4 hours at 0 hours and then 10 mLkg 16 mgkg of zegocractin IV over 4 hours at 24 48 72 and 96 hours for a total of 5 doses Patients who are randomized to the placebo group will receive 125 mLkg IV over 4 hours at 0 hours and then 10 mLkg IV over 4 hours at 24 48 72 and 96 hours for a total of 5 doses Placebo will be a matching emulsion without the active pharmaceutical ingredient zegocractin The sponsor investigators pharmacists and patients will be blinded to the assigned group The Start of First Infusion of Study Drug SFISD should occur no more than 24 hours of the patient or legally authorized representative LAR providing informed consent A study physician or appropriately trained delegate will perform study-specific hospital assessments immediately prior to the SFISD and then every 24 hours after the SFISD until 720 hours Day 30 or until discharge if earlier All patients including those that are discharged from the hospital to home or to a skilled nursing facility or to an extended care facility will be assessed at Day 90
All AKI should be managed according to the KDIGO 2012 guidelines which recommends maintaining adequate organ perfusion avoiding volume overload avoiding hyperglycemia discontinuing nephrotoxic agents and adjusting dosing of renally excreted medications AHRFacute respiratory distress syndrome ARDS should be managed according to the 2023 European Society of Intensive Care Medicine ESICM major recommendations
Patients who are randomized to the Auxora group will receive 125 mLkg 20 mgkg of zegocractin IV over 4 hours at 0 hours and then 10 mLkg 16 mgkg of zegocractin IV over 4 hours at 24 48 72 and 96 hours for a total of 5 doses Patients who are randomized to the placebo group will receive 125 mLkg IV over 4 hours at 0 hours and then 10 mLkg IV over 4 hours at 24 48 72 and 96 hours for a total of 5 doses Placebo will be a matching emulsion without the active pharmaceutical ingredient zegocractin The sponsor investigators pharmacists and patients will be blinded to the assigned group The Start of First Infusion of Study Drug SFISD should occur no more than 24 hours of the patient or legally authorized representative LAR providing informed consent A study physician or appropriately trained delegate will perform study-specific hospital assessments immediately prior to the SFISD and then every 24 hours after the SFISD until 720 hours Day 30 or until discharge if earlier All patients including those that are discharged from the hospital to home or to a skilled nursing facility or to an extended care facility will be assessed at Day 90
All AKI should be managed according to the KDIGO 2012 guidelines which recommends maintaining adequate organ perfusion avoiding volume overload avoiding hyperglycemia discontinuing nephrotoxic agents and adjusting dosing of renally excreted medications AHRFacute respiratory distress syndrome ARDS should be managed according to the 2023 European Society of Intensive Care Medicine ESICM major recommendations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None