A Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kidney Injury.
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAstraZeneca
About this trial
This study will enroll adults aged 18 to 80 years diagnosed with sepsis due to a suspected or confirmed bacterial infection, within 7 days of being admitted to the hospital, and who have also developed acute kidney injury within 72 hours of the onset of sepsis. Eligible participants will be randomly assigned to receive either AZD4144 or a placebo intravenously once daily for the number of days specified in the CSP. During this Treatment Period, participants will undergo daily safety monitoring, as well as blood and urine sample collection and other assessments. After the Treatment Period, participants will continue to be monitored for safety and other assessments during each additional day they remain hospitalized (if applicable) as well as during up to 2 follow up visits after discharge. The main goal is to compare specific kidney function measurements between those participants receiving AZD4144 and those receiving the placebo.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
AZD4144
DrugIntravenous solution of AZD4144 will be administered to randomised participants according to the treatment arm to which they have been assigned.
Placebo
DrugIntravenous solution of Placebo will be administered to randomised participants according to the treatment arm to which they have been assigned.
Treatment groups
124 Participants
are divided into 2 treatment groupsGroup A: Arm 1 (AZD4144)Experimental treatment 1 intervention
Group B: Arm 2 (Placebo)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Area Under the Curve (AUC) of 24-hour Creatinine Clearance (CrCl).
The total area under the curve for 24-hour creatinine clearance measured throughout the treatment period.
Time frame
During the treatment period.Secondary outcomes
1
Days alive and free of KRT.
The total number of calendar days in which a patient is both alive and not receiving Kidney Replacement Therapy (KRT), such as dialysis.
Time frame
Through study completion, an average of 30 days.2
Days alive and free of modified KDIGO AKI Stage 2 or 3.
The total number of calendar days in which a patient is alive and does not meet criteria for modified KDIGO Acute Kidney Injury (AKI) Stage 2 or 3. The modified KDIGO is a scale measuring AKI severity, ranging from 1 to 3 (most severe).
Time frame
Through study completion, an average of 30 days3
AUC: SCr
The area under the curve for serum creatinine to evaluate changes in renal function.
Time frame
During the treatment period.4
AUC: Serum Cystatin C
The area under the curve for serum cystatin C to evaluate changes in renal function.
Time frame
During the treatment periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov