Acute Kidney InjuryNCT01209169
Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury
An observational study of Acute Kidney Injury, run by Astute Medical, Inc. at 35 sites in 8 countries.
Trial summary
The purpose of this study is to collect blood and urine samples that may help identify and validate biomarkers for the early detection and risk assessment of 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
- 890 participants
- Where
- 35 sitesin 8 countries
- Study dates
- Sep 2010to Feb 2013
- 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 at risk for AKI.
Who may be able to join
- Males and females 21 years of age or older;
- Subjects enrolled (first sample collection) from ED or Floor admitted to the ICU within 24 hours of enrollment; Subjects enrolled from ICU admitted to the ICU within the 24 hours prior to enrollment; Expected to remain in the ICU for at least 48 hours after enrollment; Use of indwelling urinary catheter as standard care expected for at least 48 hours after enrollment; At least one of the following acute conditions within 24 hours prior to enrollment:
- (Respiratory SOFA score of ≥ 2 (PaO2/FiO2 <300)and/or Cardiovascular SOFA score of ≥ 1 (MAP < 70 mm Hg and/or any vasopressor required).
- Patient (or authorized representative) able and willing to provide written informed consent for study participation.
Who cannot join
- Special populations including women with known pregnancy, prisoners or institutionalized individuals;Previous renal transplantation;Known acutely worsening renal function prior to enrollment (e.g., any category of RIFLE criteria. Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment; Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic);Patient meets any of the following:Active bleeding with an anticipated need for > 4 units PRBC;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
35 sites in 8 countries.
35 sites in 8 countries
United States19 sites
Joseph M. Still Research Foundation, Inc.
Augusta, Georgia, 30909
University of Maryland Medical Center
Baltimore, Maryland, 21201
Beth Israel Deaconess Med. Center (BIDMC)
Boston, Massachusetts, 02215
New York Methodist Hospital
Brooklyn, New York, 11215
University of Chicago Medical Center Section of Nephrology
Chicago, Illinois, 60637
Durham VA Medical Center
Durham, North Carolina, 27705
University of Florida
Gainesville, Florida, 32610-0254
University of Louisville
Louisville, Kentucky, 40202
Bruce W. Carter Department of Veterans Affairs Medical Center
Miami, Florida, 33125
Providence Park Hospital
Novi, Michigan, 48374
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Maricopa Intergrated Health System
Phoenix, Arizona, 85008
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261
Virginia Commonwealth University
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
University of California San Diego
San Diego, California, 92103-8781
Tampa General Hospital
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
George Washington University
Washington D.C., District of Columbia, 20037
Germany6 sites
Universitätsklinikum Aachen
Aachen, 52074
UZ Brussel
Brussel, Belgium, 1090
Klinik für Anästhesie, Intensivmedizin und Schmerztherapie
Frankfurt, 60590
Universitätsklinik Frankfurt am Main
Frankfurt, 60590
Ghent University Hospital
Ghent, Belgium, 9000
Otto-von-Guericke-Universitat Magdeburg
Madgeburg, 39120
France3 sites
Edouard Herriot Hospital
Lyon, 69003
Marc Jacquet Hospital
Melun, 77000
Haut-Lévéque Hospital
Pessac, 33600
United Kingdom3 sites
Guy's and St. Thomas Hospital
London, England, SE1 7EH
King's College Hospital
London, England, SE5 9RS
Worthing Hospital
Worthing, West Sussex, BN11 2DH
About this study
The purpose of this study is to collect blood and urine samples that may help identify and validate biomarkers for the early detection and risk assessment of 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.
Evaluation of Novel Biomarkers From Acutely ill Patients at Risk for AKI.
Primary outcome measure: Identification and Validation of Biomarkers from Acutely ill patients at risk for AKI. (N=744) Secondary outcomes including follow-up (N=890).
Measured: 10/2010 to 2/2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- 890 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astute Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Kellum, MD, Principal investigator, Professor, Critical Care Medicine, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209169
- Sponsor's protocol ID
- Sapphire
- Status last verified
- Feb 2013
- First submitted
- 23 Sep 2010
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kashani K, Al-Khafaji A, Ardiles T, Artigas A, Bagshaw SM, Bell M, Bihorac A, Birkhahn R, Cely CM, Chawla LS, Davison DL, Feldkamp T, Forni LG, Gong MN, Gunnerson KJ, Haase M, Hackett J, Honore PM, Hoste EA, Joannes-Boyau O, Joannidis M, Kim P, Koyner JL, Laskowitz DT, Lissauer ME, Marx G, McCullough PA, Mullaney S, Ostermann M, Rimmele T, Shapiro NI, Shaw AD, Shi J, Sprague AM, Vincent JL, Vinsonneau C, Wagner L, Walker MG, Wilkerson RG, Zacharowski K, Kellum JA. Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury. Crit Care. 2013 Feb 6;17(1):R25. doi: 10.1186/cc12503.
PubMed 23388612Kellum JA, Artigas A, Gunnerson KJ, Honore PM, Kampf JP, Kwan T, McPherson P, Nguyen HB, Rimmele T, Shapiro NI, Shi J, Vincent JL, Chawla LS; Sapphire Investigators. Use of Biomarkers to Identify Acute Kidney Injury to Help Detect Sepsis in Patients With Infection. Crit Care Med. 2021 Apr 1;49(4):e360-e368. doi: 10.1097/CCM.0000000000004845.
PubMed 33566467McCullough PA, Ostermann M, Forni LG, Bihorac A, Koyner JL, Chawla LS, Shi J, Kampf JP, McPherson P, Kellum JA; the Sapphire Investigators. Serial Urinary Tissue Inhibitor of Metalloproteinase-2 and Insulin-Like Growth Factor-Binding Protein 7 and the Prognosis for Acute Kidney Injury over the Course of Critical Illness. Cardiorenal Med. 2019;9(6):358-369. doi: 10.1159/000502837. Epub 2019 Oct 16.
PubMed 31618746Kane-Gill SL, Ostermann M, Shi J, Joyce EL, Kellum JA. Evaluating Renal Stress Using Pharmacokinetic Urinary Biomarker Data in Critically Ill Patients Receiving Vancomycin and/or Piperacillin-Tazobactam: A Secondary Analysis of the Multicenter Sapphire Study. Drug Saf. 2019 Oct;42(10):1149-1155. doi: 10.1007/s40264-019-00846-x.
PubMed 31240688Hoste EA, McCullough PA, Kashani K, Chawla LS, Joannidis M, Shaw AD, Feldkamp T, Uettwiller-Geiger DL, McCarthy P, Shi J, Walker MG, Kellum JA; Sapphire Investigators. Derivation and validation of cutoffs for clinical use of cell cycle arrest biomarkers. Nephrol Dial Transplant. 2014 Nov;29(11):2054-61. doi: 10.1093/ndt/gfu292. Epub 2014 Sep 18.
PubMed 25237065
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT01209169
- Acronym / sponsor ID
- Sapphire
- Conditions
- Acute Kidney Injury
- Keywords
- Kidney Renal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 890 participants (actual)
- Lead sponsor
- Astute Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 27 Sep 2010 (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.
The purpose of this study is to collect blood and urine samples that may help identify and validate biomarkers for the early detection and risk assessment of 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 at risk for AKI.
Key inclusion criteria (4 listed)
- Males and females 21 years of age or older;
- Subjects enrolled (first sample collection) from ED or Floor admitted to the ICU within 24 hours of enrollment; Subjects enrolled from ICU admitted to the ICU within the 24 hours prior to enrollment; Expected to remain in the ICU for at least 48 hours after enrollment; Use of indwelling urinary catheter as standard care expected for at least 48 hours after enrollment; At least one of the following acute conditions within 24 hours prior to enrollment:
- (Respiratory SOFA score of ≥ 2 (PaO2/FiO2 <300)and/or Cardiovascular SOFA score of ≥ 1 (MAP < 70 mm Hg and/or any vasopressor required).
- Patient (or authorized representative) able and willing to provide written informed consent for study participation.
Key exclusion criteria (1 listed)
- Special populations including women with known pregnancy, prisoners or institutionalized individuals;Previous renal transplantation;Known acutely worsening renal function prior to enrollment (e.g., any category of RIFLE criteria. Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment; Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic);Patient meets any of the following:Active bleeding with an anticipated need for > 4 units PRBC;Hemoglobin < 7 g/dL;Any other condition that in the physician's opinion would contraindicate drawing serial blood samples for clinical study purposes.
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
Evaluation of Novel Biomarkers From Acutely ill Patients at Risk for AKI.
Time frame: 10/2010 to 2/2013
Primary outcome measure: Identification and Validation of Biomarkers from Acutely ill patients at risk for AKI. (N=744) Secondary outcomes including follow-up (N=890).
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 22 Feb 2013.
- Results publication: PubMed 23388612Kashani K, Al-Khafaji A, Ardiles T, Artigas A, Bagshaw SM, Bell M, Bihorac A, Birkhahn R, Cely CM, Chawla LS, Davison DL, Feldkamp T, Forni LG, Gong MN, Gunnerson KJ, Haase M, Hackett J, Honore PM, Hoste EA, Joannes-Boyau O, Joannidis M, Kim P, Koyner JL, Laskowitz DT, Lissauer ME, Marx G, McCullough PA, Mullaney S, Ostermann M, Rimmele T, Shapiro NI, Shaw AD, Shi J, Sprague AM, Vincent JL, Vinsonneau C, Wagner L, Walker MG, Wilkerson RG, Zacharowski K, Kellum JA. Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury. Crit Care. 2013 Feb 6;17(1):R25. doi: 10.1186/cc12503.
- Derived from this study: PubMed 33566467Kellum JA, Artigas A, Gunnerson KJ, Honore PM, Kampf JP, Kwan T, McPherson P, Nguyen HB, Rimmele T, Shapiro NI, Shi J, Vincent JL, Chawla LS; Sapphire Investigators. Use of Biomarkers to Identify Acute Kidney Injury to Help Detect Sepsis in Patients With Infection. Crit Care Med. 2021 Apr 1;49(4):e360-e368. doi: 10.1097/CCM.0000000000004845.
- Derived from this study: PubMed 31618746McCullough PA, Ostermann M, Forni LG, Bihorac A, Koyner JL, Chawla LS, Shi J, Kampf JP, McPherson P, Kellum JA; the Sapphire Investigators. Serial Urinary Tissue Inhibitor of Metalloproteinase-2 and Insulin-Like Growth Factor-Binding Protein 7 and the Prognosis for Acute Kidney Injury over the Course of Critical Illness. Cardiorenal Med. 2019;9(6):358-369. doi: 10.1159/000502837. Epub 2019 Oct 16.
- Derived from this study: PubMed 31240688Kane-Gill SL, Ostermann M, Shi J, Joyce EL, Kellum JA. Evaluating Renal Stress Using Pharmacokinetic Urinary Biomarker Data in Critically Ill Patients Receiving Vancomycin and/or Piperacillin-Tazobactam: A Secondary Analysis of the Multicenter Sapphire Study. Drug Saf. 2019 Oct;42(10):1149-1155. doi: 10.1007/s40264-019-00846-x.
- Derived from this study: PubMed 25237065Hoste EA, McCullough PA, Kashani K, Chawla LS, Joannidis M, Shaw AD, Feldkamp T, Uettwiller-Geiger DL, McCarthy P, Shi J, Walker MG, Kellum JA; Sapphire Investigators. Derivation and validation of cutoffs for clinical use of cell cycle arrest biomarkers. Nephrol Dial Transplant. 2014 Nov;29(11):2054-61. doi: 10.1093/ndt/gfu292. Epub 2014 Sep 18.
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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.
John Kellum, MD principal investigator
Professor, Critical Care Medicine, University of Pittsburgh
35 sites in 8 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 35 sites in 8 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 4 inclusion and 1 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 22 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Germany, France, United Kingdom, Austria and 3 more countries. 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?
Evaluation of Novel Biomarkers From Acutely ill Patients at Risk for AKI. (time frame: 10/2010 to 2/2013). 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 NCT01209169, which also lists 5 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 22 Feb 2013.