A Phase 4 interventional study of Early RASi restart strategy and Usual Care in Acute Kidney Injury, sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Treatment
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.
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.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
RASi restart will be deferred to the study participant's providers.
Drug: Usual Care
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.
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.
Also known as: renin-angiotensin system inhibitors
RASi restart will be deferred to the study participant's providers.
Feasibility- RASi use separation
Proportion of patients in the early RASi restart arm and the usual care arm who restart RASi within 72 hours of SCr downtrending by ≥0.3mg/dL from peak SCr and at hospital discharge
Time frame: From date of enrollment until date of hospital discharge or up to 90 days if remains in the hospital
Tolerability- 90 day follow up completion
Proportion of participants who complete 90 day follow up
Time frame: Up to 90 days
Tolerability- Lab evaluation post RASi
Proportion with potassium and SCr evaluations within 1-2 weeks of RASi restart
Time frame: Up to 2 weeks post hospital discharge or 90 days if patient remains in the hospital
Tolerability- SCr evaluation after hospital discharge
Proportion with SCr evaluation after hospital discharge
Time frame: Up to 90 days
Tolerability- Proteinuria evaluation
Proportion with proteinuria evaluation after hospital discharge
Time frame: Up to 90 days
Screening-to-recruitment ratio
Number of patients screened divided by the number of patients enrolled
Time frame: Total study duration, anticipated 2.5 years, up to 4 years total
Adverse events
Total number of adverse events and number of adverse events attributable to study intervention. Adverse events include: hyperkalemia (\>5.5mEq/L and \>6mEq/L), recurrent AKI (minor (30-\<50% decline) versus major (\>=50% decline) in eGFR), symptomatic hypotension or hypertension, emergency room visits, hospitalizations, increase index hospital length of stay
Time frame: Up to 90 days
90 day RASi use
Proportion with RASi use at 90 days
Time frame: Up to 90 days
Cumulative RASi exposure
Number of days with RASi use
Time frame: Up to 90 days
Days to RASi restart
Days to RASi restart from day of peak SCr
Time frame: Up to 90 days
Plan to share: Yes — Individual participant data collected after deidentification
Supporting information: Study protocol
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University of California, San Francisco