RECRUITING

Clinical Validation of the RENISCHEM L-FABP POC Assay

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-10-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04864847

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients age 18 or older on the day of the procedure
  2. * 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
  3. * Able to provide informed consent
  4. * Available to participate in follow-up visits
  5. * eGFR \< 45 within the last 90 days, or
  6. * eGFR \< 60 within the last 90 days with at least one (1) of the following risk factors:
  7. * Diabetes
  8. * Heart failure (acute or chronic)
  9. * Anemia (hemoglobin \< 12 g/dL for females and \< 13 g/dL for males) within the last 90 days
  10. * Age \> 75 on the day of the procedure
  1. * Patient on dialysis or with eGFR \< 15 within the last 30 days
  2. * History of renal transplant
  3. * Current use of immunosuppressive drugs other than prednisone \< 10 mg/day
  4. * Current clinically significant infection (including HIV, hepatitis)
  5. * Presence of KDIGO Stage 1, 2, or 3 AKI within the last 7 days, according to KDIGO criteria
  6. * Known or suspected nephritic or nephrotic syndrome.
  7. * A current post-renal etiology of renal impairment
  8. * Known allergy or hypersensitivity to radiographic contrast dye that cannot be pre-medicated
  9. * Females that are known to be pregnant or nursing
  10. * 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

Contacts and Locations

Study Contact

Jeffrey Dahlen, Ph.D.
CONTACT
(619) 742-0203
jeff@hikaridx.com

Principal Investigator

Peter McCullough
PRINCIPAL_INVESTIGATOR
Independent

Study Locations (Sites)

Chandler Regional Medical Center
Chandler, Arizona, 85224
United States
John Muir Health
Concord, California, 94520
United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756
United States
University of Florida at Jacksonville
Jacksonville, Florida, 32209
United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104
United States

Collaborators and Investigators

Sponsor: Hikari Dx, Inc.

  • Peter McCullough, PRINCIPAL_INVESTIGATOR, Independent

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-10-01
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • L-FABP
  • Point of Care

Additional Relevant MeSH Terms

  • Acute Kidney Injury
  • Contrast-induced Nephropathy