Outpatient Recovery From Acute Kidney Injury Requiring Dialysis - 2

NCT07106151 | Recruiting

• 2 other identifiers: 25-445315K23DK128605
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Providing additional information to patients with acute kidney injury who continue dialysis after hospital discharge and to the accepting kidney doctor (nephrologist) who manages their dialysis may be feasible and beneficial. This study will pilot measuring the patient's residual kidney function at the time of discharge and communicating that result to the accepting nephrologist and the patient, along with information on recommended recovery monitoring frequency and criteria for consideration of a twice-weekly hemodialysis schedule.

Conditions

AKI; AKI - Acute Kidney Injury; Dialysis Patients

Outcome Measures

Primary Outcomes (1)

• Feasibility: The proportion of patients who complete the timed urine collection within seven days before discharge and are able to have the results successfully transmitted to the accepting nephrologist and patient.

  Baseline

Secondary Outcomes (7)

• Recruitment rate: Number of patients enrolled per month

  Total study duration, anticipated 2 years

• Screening-to-recruitment ratio: Number of patients who meet inclusion criteria divided by the number of patients enrolled.

  Total study duration, anticipated 2 years

• Number of post-discharge urine collections completed

  Study day 60

• Proportion prescribed a <3x/wk hemodialysis schedule at any time within 60 days of hospital discharge

  Study day 60

• Proportion who recover from needing dialysis

  Study day 60

Study Arms (2)

Additional AKI-D recovery information

EXPERIMENTAL

Behavioral: Transmission of additional AKI-D recovery information

No additional AKI-D recovery information

ACTIVE COMPARATOR

Other: No additional AKI-D recovery information

Interventions

Transmission of additional AKI-D recovery information BEHAVIORAL

Measuring residual kidney function at the time of hospital discharge by timed urine collection (6-24 hours in duration), transmitting the results (urine volume, urea clearance, and creatinine clearance) to the accepting nephrologist and to the patient, along with information on recommended recovery monitoring frequency and criteria for consideration of a twice-weekly hemodialysis schedule.

Additional AKI-D recovery information

No additional AKI-D recovery information OTHER

The same timed urine collection will be collected at the time of hospital discharge as in the intervention arm, but in the control arm the results will not be transmitted to the accepting nephrologist or to the patient and no information on recommended recovery monitoring frequency and criteria for consideration of a twice-weekly hemodialysis schedule will be transmitted. Instead, the research team will call the accepting nephrologist to alert them that this is an AKI-D patient that is being followed by the research team for recovery for up to 60 days.

No additional AKI-D recovery information

Eligibility Criteria

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

You may qualify if:

• AKI-D (not ESKD, as determined by the clinical inpatient nephrology team)
• Age ≥ 18 years
• Planned for continued dialysis outside the acute hospital setting (at outpatient dialysis unit/SNF/LTACH, not planned transfer to another short-stay acute care hospital).

You may not qualify if:

• Pregnant
• Prisoner
• Unable to consent and no surrogate decision maker available
• Clinical team declines to allow approach for study

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

RECRUITING

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

• Ian E McCoy, MD, MS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian E McCoy, MD, MS

CONTACT

415-353-2507; ian.mccoy@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 6, 2025
• Study Start: February 23, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)