Renin-Angiotensin System Inhibitors for Acute Kidney Injury
(APRES-AKI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this pilot clinical trial is to learn if early restart of renin-angiotensin system inhibitor (RASi) medications is feasible and well-tolerated in hospitalized patients with acute kidney injury (AKI). Researchers will compare early RASi restart to usual care.
Study participants will restart RASi per study protocol, obtain a lab test in 1-2 weeks if RASi restarted in the hospital and not collected as part of routine care, and answer questions at the 90-day follow-up.
Who Is on the Research Team?
Yuenting D Kwong, MD MAS
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for adults who were hospitalized with acute kidney injury and had been taking renin-angiotensin system inhibitor (RASi) medications before their illness. People with other serious conditions or reasons not to restart RASi may not be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants restart RASi as soon as serum creatinine downtrends by ≥0.3mg/dL from peak, with additional criteria for potassium, eGFR, and blood pressure
Follow-up
Participants are monitored for safety and effectiveness, including lab evaluations and follow-up questions at 90 days
Extension
Participants may continue to be monitored for adverse events and RASi use
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares restarting RASi medications early after an episode of acute kidney injury versus following usual care practices. Participants are randomly assigned to either group, and labs plus follow-up questions are used to monitor outcomes.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The early restart strategy is to resume RASi as soon as the serum creatinine (SCr) downtrends by ≥0.3mg/dL from peak. In addition, the following criteria must be met: most recent potassium ≤5mEq/L, SCr-based eGFR reported as ≥15 mL/min/1.73m2, and average systolic blood pressure≥120mmHg 12 hours prior to restart. If the study participant is discharged from the hospital before the RASi restart criteria are met, management of RASi restart would be deferred to the discretion of longitudinal outpatient healthcare team.
RASi restart will be deferred to the study participant's providers.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
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