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Acute Kidney InjurySAKURA-POCNCT04864847

Clinical Validation of the RENISCHEM L-FABP POC Assay

An observational study of Acute Kidney Injury and Contrast-induced Nephropathy, run by Hikari Dx, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will involve measurement of levels of a novel urinary biomarker of renal ischemia, L-FABP. The purpose of the study is to perform a clinical validation of the ability of L-FABP measurements in urine using the RENISCHEM L-FABP POC Test to predict the development of AKI within 2 days following cardiac and… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
RENISCHEM L-FABP POC Test
How many people
382 participants
Where
6 sitesUnited States
Study dates
1 Oct 2021to 5 Feb 2026
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population will include patients recruited from a healthcare setting that will be undergoing cardiac or vascular interventional procedures that are at elevated risk for developing AKI. At least 50% of the enrolled population will be undergoing an interventional procedure such as percutaneous coronary intervention (PCI), transcatheter aortic valve replacement (TAVR) or transcatheter aortic valve implantation (TAVI).

Who may be able to join

  • Patients age 18 or older on the day of the procedure
  • Undergoing cardiac or vascular interventional procedures for diagnostic angiography, coronary intervention, TAVR or TAVI, with planned use of radiocontrast media within the next 30 days
  • Able to provide informed consent
  • Available to participate in follow-up visits
  • eGFR < 45 within the last 90 days, or
  • eGFR < 60 within the last 90 days with at least one (1) of the following risk factors:
Show all 10Show fewer
  • Diabetes
  • Heart failure (acute or chronic)
  • Anemia (hemoglobin < 12 g/dL for females and < 13 g/dL for males) within the last 90 days
  • Age > 75 on the day of the procedure

Who cannot join

  • Patient on dialysis or with eGFR < 15 within the last 30 days
  • History of renal transplant
  • Current use of immunosuppressive drugs other than prednisone < 10 mg/day
  • Current clinically significant infection (including HIV, hepatitis)
  • Presence of KDIGO Stage 1, 2, or 3 AKI within the last 7 days, according to KDIGO criteria
  • Known or suspected nephritic or nephrotic syndrome.
Show all 10Show fewer
  • A current post-renal etiology of renal impairment
  • Known allergy or hypersensitivity to radiographic contrast dye that cannot be pre-medicated
  • Females that are known to be pregnant or nursing
  • Participation within the last 30 days in another clinical trial involving use of any drug known to affect AKI and/or device known to affect AKI

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Chandler Regional Medical Center

    Chandler, Arizona, 85224

  • Clearwater Cardiovascular Consultants

    Clearwater, Florida, 33756

  • John Muir Health

    Concord, California, 94520

  • University of Florida at Jacksonville

    Jacksonville, Florida, 32209

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

Other trials in United States

About this study

Official title: A Study of Contrast-induced Acute Kidney Injury Prediction Using the RENISCHEM L-FABP Assay at the Point-of-Care

This study will involve measurement of levels of a novel urinary biomarker of renal ischemia, L-FABP. The purpose of the study is to perform a clinical validation of the ability of L-FABP measurements in urine using the RENISCHEM L-FABP POC Test to predict the development of AKI within 2 days following cardiac and vascular catheterization procedures involving exposure to radiocontrast media.

Read the detailed description

This study will validate the ability of the RENISCHEM L-FABP POC test to predict AKI risk in patients undergoing cardiac catheterization and receiving iodinated contrast medium. Contrast medium is known to be both vasoconstrictive and chemotoxic, which can lead to renal ischemia and, ultimately, AKI. Infusion of radiographic contrast agents, with the associated increases in osmotic load and viscosity, increases hypoxia of the renal medulla and increases renal free radical production through post-ischemic oxidative stress. Earlier identification of contrast medium-induced acute kidney injury (CI-AKI) risk can facilitate improved management of patients to prevent AKI, for example, through selection of alternative imaging methods or contrast agents.

Subjects will be recruited prospectively based on pre-specified enrollment criteria. Blood and urine samples will be collected after enrollment and at several timepoints, and various tests will be performed, including point-of-care L-FABP measurements on urine samples.

Being tested
RENISCHEM L-FABP POC Test
Keywords
L-FABP, Point of Care
Medical subject headings
Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RENISCHEM L-FABP POC TestDiagnostic test

    Point-of-care test cassette with quantitative reader used for the measurement of L-type fatty acid binding protein (L-FABP) in human urine specimens.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Development of acute kidney injury

    AKI defined as stage 1, 2, or 3 using the KDIGO criteria

    Measured: Within 2 days after a cardiac or vascular catheterization procedure involving the use of contrast media

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2021
  2. Study start1 Oct 2021
  3. Primary completion5 Feb 2026
  4. Study completion5 Feb 2026

Resources

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
382 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04864847
Sponsor's protocol ID
TWM-001
Acronym
SAKURA-POC
Status last verified
Jun 2026
First submitted
26 Apr 2021
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Noiri E, Doi K, Negishi K, Tanaka T, Hamasaki Y, Fujita T, Portilla D, Sugaya T. Urinary fatty acid-binding protein 1: an early predictive biomarker of kidney injury. Am J Physiol Renal Physiol. 2009 Apr;296(4):F669-79. doi: 10.1152/ajprenal.90513.2008. Epub 2008 Nov 19.

    PubMed 19019918

  • Yamamoto T, Noiri E, Ono Y, Doi K, Negishi K, Kamijo A, Kimura K, Fujita T, Kinukawa T, Taniguchi H, Nakamura K, Goto M, Shinozaki N, Ohshima S, Sugaya T. Renal L-type fatty acid--binding protein in acute ischemic injury. J Am Soc Nephrol. 2007 Nov;18(11):2894-902. doi: 10.1681/ASN.2007010097. Epub 2007 Oct 17.

    PubMed 17942962

  • Fujita D, Takahashi M, Doi K, Abe M, Tazaki J, Kiyosue A, Myojo M, Ando J, Fujita H, Noiri E, Sugaya T, Hirata Y, Komuro I. Response of urinary liver-type fatty acid-binding protein to contrast media administration has a potential to predict one-year renal outcome in patients with ischemic heart disease. Heart Vessels. 2015 May;30(3):296-303. doi: 10.1007/s00380-014-0484-9. Epub 2014 Feb 20.

    PubMed 24554034

  • Kamijo-Ikemori A, Hashimoto N, Sugaya T, Matsui K, Hisamichi M, Shibagaki Y, Miyake F, Kimura K. Elevation of urinary liver-type fatty acid binding protein after cardiac catheterization related to cardiovascular events. Int J Nephrol Renovasc Dis. 2015 Aug 18;8:91-9. doi: 10.2147/IJNRD.S88467. eCollection 2015.

    PubMed 26316797

  • Manabe K, Kamihata H, Motohiro M, Senoo T, Yoshida S, Iwasaka T. Urinary liver-type fatty acid-binding protein level as a predictive biomarker of contrast-induced acute kidney injury. Eur J Clin Invest. 2012 May;42(5):557-63. doi: 10.1111/j.1365-2362.2011.02620.x. Epub 2011 Nov 10.

    PubMed 22070248

  • Nakamura T, Sugaya T, Node K, Ueda Y, Koide H. Urinary excretion of liver-type fatty acid-binding protein in contrast medium-induced nephropathy. Am J Kidney Dis. 2006 Mar;47(3):439-44. doi: 10.1053/j.ajkd.2005.11.006.

    PubMed 16490622

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Kidney Injury and Contrast-induced Nephropathy, run by Hikari Dx, Inc. at 6 sites in United States.

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 10 inclusion and 10 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 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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?

Development of acute kidney injury (time frame: Within 2 days after a cardiac or vascular catheterization procedure involving the use of contrast media). 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 NCT04864847, which also lists 6 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 10 Jun 2026.

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