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NCT07734636PHASE4Recruiting

A Prompt REstart Study of Renin-Angiotensin System Inhibitors After Acute Kidney Injury

University of California, San Francisco

Start Date

9/1/2026

Completion Date

3/1/2029

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.

Detailed Description

Among at-risk patients with heart failure and chronic kidney disease, use of RASi medications decreases the subsequent risk of adverse events such as cardiovascular death and kidney disease progression. However, RASi treatment is often stopped when AKI is detected in the hospital based on the notion that restoring an intact renin-angiotensin system in the context of hypovolemia or hypotension may be helpful to maintain perfusion to the glomeruli and thus support the glomerular filtration rate. In observational studies, restart of RASi medications among at-risk patients after AKI has been associated with decreased subsequent rates of mortality, cardiovascular events, and kidney disease progression. However, there is no rigorous evidence from randomized trials to guide optimal strategy of RASi restart after AKI. This is a pilot trial among hospitalized patients with AKI whose RASi were held to investigate the feasibility and tolerability of a strategy of early RASi restart (n=30) compared to usual care (n=30). This pilot trial will provide valuable data critical to inform the design of a larger definitive trial. The study hypothesis is that the strategy of early RASi restart after AKI is feasible and well-tolerated. This pilot trial will inform the design of a larger definitive trial to determine whether early RASi restart can increase rates of RASi use at 90 days compared to usual care.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Age ≥ 18 years * Pre-admission RASi use for Class I indication (e.g., heart failure, kidney disease) * RASi stopped in the setting of AKI (defined by ≥1.5x baseline SCr) * AKI in recovery (defined by a decrease in SCr by ≥0.3mg/dL from peak) Exclusion Criteria: * RASi allergy or contraindication (i.e., angioedema, bilateral renal artery stenosis) * Ongoing dialysis requirement * Pregnant or breastfeeding * Prisoner * Palliative or hospice care involvement * Unable to consent * No enteral route of medication administration * Clinician judgment

Interventions

DRUG

Early RASi restart strategy

DRUG

Usual Care

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Conditions

Acute Kidney Injury

Locations

University of California, San Francisco

San Francisco, California 94143

United States