Recruiting

RASi vs. Usual Care

Sponsor:

UCLA

Code:

NCT07734636

Conditions

Acute Kidney Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Early RASi restart strategy

Usual Care

Study Details

Brief 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

Acute Kidney Injury

Study ID

NCT07734636

Start date

Sep 1, 2026

Status verified date

Sep, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Usual Care

RASi restart will be deferred to the study participant's providers.

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 and Locations

Central contacts

Yuenting D Kwong, MD MAS

415-514-7371diana.kwong@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Yuenting D Kwong, MD MAS

415-514-7371diana.kwong@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Acute kidney injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-09-08.