A Prompt REstart Study of Renin-Angiotensin System Inhibitors After Acute Kidney Injury
NCT07734636 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-07-29
Summary
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.
Conditions
Interventions
- DRUG
-
Early RASi restart strategy
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, CKD-EPI SCr-based eGFR reported as ≥15 mL/min/1.73m2, and average SBP ≥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.
- DRUG
-
Usual Care
RASi restart will be deferred to the study participant's providers.
Sponsors & Collaborators
-
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
collaborator NIH -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Yuenting D Kwong, MD MAS · University of California, San Francisco
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-31
- Primary Completion
- 2029-03-31
- Completion
- 2029-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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