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 — DRUG
    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.
  • Usual Care — DRUG
    RASi 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 care
    RASi restart will be deferred to the study participant's providers.
  • Experimental: 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, 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

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Yuenting D Kwong, MD MAS
415-514-7371

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