AZD4144 for Acute Kidney Injury
(SERENIA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called AZD4144 for individuals who develop acute kidney injury (AKI) following sepsis, a serious infection. The goal is to determine if AZD4144 can improve kidney function compared to a placebo, a substance with no active drug. Participants will receive daily doses of either AZD4144 or the placebo, with close monitoring of their kidney function. The trial seeks individuals hospitalized for no more than 7 days, with sepsis from a bacterial infection, and who developed AKI within three days of the onset of sepsis. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants will be excluded if they have received certain medications before enrollment or are expected to need specific medications during the trial. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that AZD4144 is likely to be safe for humans?
Research has shown that AZD4144 has generally been well-tolerated in earlier studies. One study examined individuals with severe kidney problems and found AZD4144 safe for them. Another report indicated that AZD4144 reduced harmful inflammation in lab tests and helped protect kidney function in animals.
While these studies suggest AZD4144 is safe, it's important to remember that this treatment remains under investigation. This trial is in the middle phase, meaning AZD4144 has shown some safety in earlier research, but more information is needed to confirm this in humans. Researchers will closely monitor participants for any side effects.12345Why do researchers think this study treatment might be promising?
AZD4144 is unique because it represents a new approach to treating acute kidney injury. Unlike the standard treatments, which often involve supportive care like dialysis or medications to manage symptoms, AZD4144 is an experimental drug delivered via IV infusion that aims to directly address kidney function. Researchers are excited about AZD4144 because it might work by a novel mechanism that offers a more targeted intervention, potentially improving outcomes for patients with acute kidney injury faster and more effectively than current options.
What evidence suggests that AZD4144 might be an effective treatment for acute kidney injury?
Research has shown that AZD4144, which participants in this trial may receive, could help treat sudden kidney problems caused by sepsis. Studies have found that AZD4144 is safe and well-tolerated in people with serious kidney issues. This medication works by affecting certain pathways that may improve kidney function. Early results suggest that AZD4144 might help reduce kidney damage and aid recovery. Although more information is needed, these findings offer hope for those facing kidney problems due to sepsis.13678
Are You a Good Fit for This Trial?
Adults aged 18-80 with sepsis from a bacterial infection, hospitalized within the past week, and who developed acute kidney injury within 72 hours of sepsis onset. Participants must not have conditions that would exclude them as per the trial's specific criteria.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravenous AZD4144 or placebo daily with daily safety monitoring and sample collection
Follow-up
Participants are monitored for safety and effectiveness after treatment, including daily assessments while hospitalized and up to two outpatient visits after discharge
What Are the Treatments Tested in This Trial?
Interventions
- AZD4144
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology