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

NCT07734636 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 25-45052K23DK139456
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Acute kidney injury

Outcome Measures

Primary Outcomes (1)

• Feasibility- RASi use separation

  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

Secondary Outcomes (4)

• Tolerability- 90 day follow up completion

  Up to 90 days

• Tolerability- Lab evaluation post RASi

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

• Tolerability- SCr evaluation after hospital discharge

  Up to 90 days

• Tolerability- Proteinuria evaluation

  Up to 90 days

Other Outcomes (5)

• Screening-to-recruitment ratio

  Total study duration, anticipated 2.5 years, up to 4 years total

• Adverse events

  Up to 90 days

• 90 day RASi use

  Up to 90 days

Study Arms (2)

Usual care

ACTIVE COMPARATOR

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

Drug: Usual Care

Early RASi restart strategy

EXPERIMENTAL

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.

Drug: Early RASi restart strategy

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.

Also known as: renin-angiotensin system inhibitors

Early RASi restart strategy

Usual Care DRUG

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

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Yuenting D Kwong, MD MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuenting D Kwong, MD MAS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot 2-arm parallel-comparison randomized clinical trial comparing early RASi restart strategy to usual care

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 29, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)