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NCT Number: NCT07106151

Outpatient Recovery From Acute Kidney Injury Requiring Dialysis - 2

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.

Recruiting

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Key information

Conditions

AKI AKI - Acute Kidney Injury Acute Kidney Injury Dialysis Patients 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

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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).

Exclusion criteria

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

Treatment and study plan

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.

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.

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.

    Time frame: Baseline

Secondary outcomes

  1. Recruitment rate: Number of patients enrolled per month

    Time frame: Total study duration, anticipated 2 years

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

    Time frame: Total study duration, anticipated 2 years

  3. Number of post-discharge urine collections completed

    Time frame: Study day 60

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

    Time frame: Study day 60

  5. Proportion who recover from needing dialysis

    Time frame: Study day 60

  6. Proportion who trial a <3x/wk hemodialysis schedule but subsequently need to be increased to >= 3x/wk during the 60-day follow-up.

    Time frame: Study day 60

  7. Incidence of adverse events

    Time frame: Study day 60

Study contacts

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

Ian E McCoy, MD, MS

CONTACT

[email protected]

415-353-2507

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: ORKID-2

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 6, 2025
Registry last updated
Feb 27, 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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