A Prompt REstart Study of Renin-Angiotensin System Inhibitors After Acute Kidney Injury
Part of paid clinical trials in San Francisco, California.
- Sponsor
- University of California, San Francisco
- Study ID
- NCT07734636
- Phase
- PHASE4
- Status
- Not Yet Recruiting
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Conditions
- Acute Kidney Injury
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Early RASi restart strategy — DRUGThe 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.
- Usual Care — DRUGRASi restart will be deferred to the study participant's providers.
Study Details
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.
Key Dates
- First listed
- Jul 29, 2026
- Start date
- Aug 31, 2026
- Status verified
- Jul 2026
- Primary completion
- Mar 31, 2029
- Completion
- Mar 31, 2029
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Usual careRASi restart will be deferred to the study participant's providers.
- Experimental: Early RASi restart strategyThe 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.
Primary Outcome Measure
Feasibility- RASi use separation [ Time Frame: From date of enrollment until date of hospital discharge or up to 90 days if remains in the hospital ]
Central Contacts
- Yuenting D Kwong, MD MAS415-514-7371
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 |
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