Acute Kidney InjuryNCT01868724
Identification and Validation of Biomarkers of Acute Kidney Injury Recovery
An observational study of Acute Kidney Injury, run by Astute Medical, Inc. at 21 sites in 6 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 362 participants
- Where
- 21 sitesin 6 countries
- Study dates
- Jun 2013to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult ICU Patients with AKI
Who may be able to join
- 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)
Who cannot join
- 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:
Show all 9Show fewer
- 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
Trial locations and contacts
21 sites in 6 countries.
21 sites in 6 countries
United States12 sites
Study site
Akron, Ohio, 44304
Study site
Ann Arbor, Michigan, 48109
Study site
Baltimore, Massachusetts, 21201
Study site
Chicago, Illinois, 60611
Study site
Chicago, Illinois, 60637
Study site
Cleveland, Ohio, 44195
Study site
Durham, North Carolina, 27705
Study site
Gainesville, Florida, 32610
Study site
Nashville, Tennessee, 37232
Study site
Pittsburgh, Pennsylvania, 15212
Study site
Pittsburgh, Pennsylvania, 15261
Study site
Washington D.C., District of Columbia, 20037
United Kingdom3 sites
Study site
London, E1 1BB
Study site
London, SE1 7EH
Study site
West Sussex, BN11 2DH
About this study
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).
- Conditions
- Acute Kidney Injury
- Keywords
- Kidney Renal
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1-7 of enrollment
Secondary outcomes (1)
None at this time
There are no secondary outcomes measures planned at this time
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astute Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lakhmir S Chawla, M.D., Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868724
- Sponsor's protocol ID
- Ruby
- Status last verified
- Sep 2014
- First submitted
- 21 May 2013
- Last updated
- 13 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 35919538Hoste 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.
PubMed 32025755
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Validation of Biomarkers of Acute Kidney Injury Recovery
- ClinicalTrials.gov ID
- NCT01868724
- Acronym / sponsor ID
- Ruby
- Conditions
- Acute Kidney Injury
- Keywords
- Kidney Renal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Astute Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ICU Patients with AKI
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation of biomarkers for Acute Kidney Injury Recovery in Blood or Urine.
Time frame: Day 1-7 of enrollment
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.
1 secondary outcome
None at this time
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2015.
- Derived from this study: PubMed 35919538Koyner 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.
- Derived from this study: PubMed 32025755Hoste 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lakhmir S Chawla, M.D. principal investigator
George Washington University
21 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Astute Medical, Inc. at 21 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, United Kingdom, Belgium, Germany, Austria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of biomarkers for Acute Kidney Injury Recovery in Blood or Urine. (time frame: Day 1-7 of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01868724, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2015.