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NCT Number: NCT07734636

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

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Location status: Recruiting

Location contact

Yuenting D Kwong, MD MAS

CONTACT

[email protected]

415-514-7371

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: renin-angiotensin system inhibitors

Usual Care

Drug

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

Primary outcomes

  1. 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

    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

Secondary outcomes

  1. Tolerability- 90 day follow up completion

    Time frame: Up to 90 days

    Proportion of participants who complete 90 day follow up

  2. Tolerability- Lab evaluation post RASi

    Time frame: Up to 2 weeks post hospital discharge or 90 days if patient remains in the hospital

    Proportion with potassium and SCr evaluations within 1-2 weeks of RASi restart

  3. Tolerability- SCr evaluation after hospital discharge

    Time frame: Up to 90 days

    Proportion with SCr evaluation after hospital discharge

  4. Tolerability- Proteinuria evaluation

    Time frame: Up to 90 days

    Proportion with proteinuria evaluation after hospital discharge

Other outcomes

  1. Screening-to-recruitment ratio

    Time frame: Total study duration, anticipated 2.5 years, up to 4 years total

    Number of patients screened divided by the number of patients enrolled

  2. Adverse events

    Time frame: Up to 90 days

    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

  3. 90 day RASi use

    Time frame: Up to 90 days

    Proportion with RASi use at 90 days

  4. Cumulative RASi exposure

    Time frame: Up to 90 days

    Number of days with RASi use

  5. Days to RASi restart

    Time frame: Up to 90 days

    Days to RASi restart from day of peak SCr

Study contacts

Contact information is provided by the study sponsor or research team.

Yuenting D Kwong, MD MAS

CONTACT

[email protected]

415-514-7371

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: APRES-AKI

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 29, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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