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A Prompt REstart Study of Renin-Angiotensin System Inhibitors After Acute Kidney Injury (APRES-AKI)

4 september 2026 uppdaterad av: University of California, San Francisco

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

60

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • California
      • San Francisco, California, Förenta staterna, 94143
        • Rekrytering
        • University of California, San Francisco
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Usual care
RASi restart will be deferred to the study participant's providers.
Läkemedel: Usual Care
RASi restart will be deferred to the study participant's providers.
Experimentell: 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.
Läkemedel: 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.
Andra namn:
  • renin-angiotensin system inhibitors

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Feasibility- RASi use separation
Tidsram: 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
From date of enrollment until date of hospital discharge or up to 90 days if remains in the hospital

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Tolerability- 90 day follow up completion
Tidsram: Up to 90 days
Proportion of participants who complete 90 day follow up
Up to 90 days
Tolerability- Lab evaluation post RASi
Tidsram: 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
Up to 2 weeks post hospital discharge or 90 days if patient remains in the hospital
Tolerability- SCr evaluation after hospital discharge
Tidsram: Up to 90 days
Proportion with SCr evaluation after hospital discharge
Up to 90 days
Tolerability- Proteinuria evaluation
Tidsram: Up to 90 days
Proportion with proteinuria evaluation after hospital discharge
Up to 90 days

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Screening-to-recruitment ratio
Tidsram: Total study duration, anticipated 2.5 years, up to 4 years total
Number of patients screened divided by the number of patients enrolled
Total study duration, anticipated 2.5 years, up to 4 years total
Adverse events
Tidsram: 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
Up to 90 days
90 day RASi use
Tidsram: Up to 90 days
Proportion with RASi use at 90 days
Up to 90 days
Cumulative RASi exposure
Tidsram: Up to 90 days
Number of days with RASi use
Up to 90 days
Days to RASi restart
Tidsram: Up to 90 days
Days to RASi restart from day of peak SCr
Up to 90 days

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of California, San Francisco

Samarbetspartners

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

Utredare

  • Huvudutredare: Yuenting D Kwong, MD MAS, University of California, San Francisco

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 september 2026

Primärt slutförande (Beräknad)

1 mars 2029

Avslutad studie (Beräknad)

1 mars 2029

Studieregistreringsdatum

Först inskickad

16 juli 2026

Först inskickad som uppfyllde QC-kriterierna

23 juli 2026

Första postat (Faktisk)

29 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 25-45052
  • K23DK139456 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Individual participant data collected after deidentification

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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