Identification and Validation of Biomarkers of Acute Kidney Injury Recovery

This study is to collect blood and urine samples to help identify and validate protein biomarkers of recovery from moderate or severe acute kidney injury (AKI).

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury

• Study Type: Observational
• Enrollment (Actual): 362

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
• Belgium
  • Brussels, Belgium, 1090
  • Ghent, Belgium, 9000
• Germany
  • Frankfurt, Germany, 60590
  • Madgeburg, Germany, 39120
• Spain
  • Sabadelle, Spain, 08208
• United Kingdom
  • London, United Kingdom, SE1 7EH
  • London, United Kingdom, E1 1BB
  • West Sussex, United Kingdom, BN11 2DH
• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
  • Florida
    • Gainesville, Florida, United States, 32610
  • Illinois
    • Chicago, Illinois, United States, 60637
    • Chicago, Illinois, United States, 60611
  • Massachusetts
    • Baltimore, Massachusetts, United States, 21201
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
  • North Carolina
    • Durham, North Carolina, United States, 27705
  • Ohio
    • Akron, Ohio, United States, 44304
    • Cleveland, Ohio, United States, 44195
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
    • Pittsburgh, Pennsylvania, United States, 15212
  • Tennessee
    • Nashville, Tennessee, United States, 37232

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult ICU Patients with AKI

Description

Inclusion Criteria:a.

• Males and females 21 years of age or older
• Receiving care in an intensive care unit
• Expected to remain in the ICU for at least 48 hours after enrollment
• Use of indwelling urinary catheter as standard care at the time of enrollment
• Subject must have acute kidney injury (KDIGO stage 2 or stage 3) at the time of the first sample collection
• First sample must be collected within 36 hours of meeting KDIGO stage 2 criteria
• Written informed consent provided by patient or legally authorized representative (LAR)

Exclusion Criteria:

• Prior kidney transplantation
• Comfort-measures-only status
• Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment
• History of human immunodeficiency virus (HIV) or hepatitis virus (based upon available medical records) infections (NOTE: HIV or hepatitis testing need not be performed for enrollment in this study.)
• Special populations, pregnant women, prisoners or institutionalized individuals

• Patient meets any of the following:

  • Active bleeding with an anticipated need for > 4 units PRBC in a day
  • Hemoglobin < 7 g/dL
  • Any other condition that in the physician's opinion would contraindicate drawing serial blood samples for clinical study purposes

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of biomarkers for Acute Kidney Injury Recovery in Blood or Urine.	This study is a multi-center study intended to enroll enough subjects to validate biomarkers for acute kidney injury recovery. Subjects enrolled will be those with known moderate to severe AKI. The study is to determine the outcome of Major Adverse Kidney Event (MAKE) and Major Adverse Cardiac Event (MACE) during a period of up to 7 days.	Day 1-7 of enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
None at this time	There are no secondary outcomes measures planned at this time	10 months

Collaborators and Investigators

• Sponsor: Astute Medical, Inc.
• Investigators: Principal Investigator: Lakhmir S Chawla, M.D., George Washington University

Publications and helpful links

General Publications

• Koyner JL, Chawla LS, Bihorac A, Gunnerson KJ, Schroeder R, Demirjian S, Hodgson L, Frey JA, Wilber ST, Kampf JP, Kwan T, McPherson P, Kellum JA; RUBY investigators. Performance of a Standardized Clinical Assay for Urinary C-C Motif Chemokine Ligand 14 (CCL14) for Persistent Severe Acute Kidney Injury. Kidney360. 2022 Mar 24;3(7):1158-1168. doi: 10.34067/KID.0008002021. eCollection 2022 Jul 28.
• Hoste E, Bihorac A, Al-Khafaji A, Ortega LM, Ostermann M, Haase M, Zacharowski K, Wunderink R, Heung M, Lissauer M, Self WH, Koyner JL, Honore PM, Prowle JR, Joannidis M, Forni LG, Kampf JP, McPherson P, Kellum JA, Chawla LS; RUBY Investigators. Identification and validation of biomarkers of persistent acute kidney injury: the RUBY study. Intensive Care Med. 2020 May;46(5):943-953. doi: 10.1007/s00134-019-05919-0. Epub 2020 Feb 6.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: May 21, 2013
• First Submitted That Met QC Criteria: June 3, 2013
• First Posted (Estimate): June 4, 2013

Study Record Updates

• Last Update Posted (Estimate): March 13, 2015
• Last Update Submitted That Met QC Criteria: March 12, 2015
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Kidney Renal
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: Ruby