Real-time Early Detection of Nephrotoxicity by Urinary Biomarker Analysis With SeroFlow Technology (RenaFAST)

November 6, 2023 updated by: National University Hospital, Singapore

Real-time Early Detection of Nephrotoxicity by Accurate and Faster Urinary Biomarker Analysis With SeroFlow Technology (RenaFAST Study)

The study aims to perform real-time validation of the RenaFAST kit (a point-of-care test kit that quantifies three urinary proteins) in predicting acute kidney injury(AKI) among patients prescribed drug therapies of nephrotoxic potential. Based on the type and duration of drug therapy, a maximum of 5 time-point urine samples will be collected from consenting patients and a real-time biomarker analysis will be conducted using the RenaFAST kits.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All eligible patients who fulfill the inclusion and exclusion criteria will be approached for consent. The patients with the highest AKI risk (with all 3 urine biomarkers, Clusterin, monocyte chemoattractant protein-1 (MCP1), and Beta-2 microglobulin (ß2MG), above prediction threshold set by the study) will be identified. The nephrology consultants within the research team will perform a medical chart and physical review(where required) of these patients, noting potential actions to be taken in data collection forms. This will help in evaluating if indeed there are perceived interventions that could potentially be delivered in response to early prediction of AKI.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who receive a projected ≥7 days of therapy of antimicrobials including aminoglycosides (i.e., gentamicin or amikacin), vancomycin, polymyxin, amphotericin and foscarnet.
  • Patients who receive a projected ≥7 days of Calcineurin inhibitors (cyclosporin, tacrolimus)
  • Patients who receive a projected ≥7 days of anti-virals (Cidofovir and Ganciclovir)
  • Patients who receive Anti-cancer drugs (Chemotherapy such as cisplatin, Ifosfamide, Methotrexate, Pemetrexed) or
  • Patients who receive Anti-cancer drugs (Immunotherapy such as immune checkpoint inhibitors as well as types of VGEF inhibitors that are associated with acute kidney injury)

Exclusion Criteria:

  • Patients with AKI prior to therapy initiation.
  • Patients with baseline eGFR < 15 mL/min/1.73m2 (stage 5 chronic kidney disease)
  • Patients admitted to intensive care unit at study baseline, as critical illness is a natural confounder to AKI
  • Females who are pregnant
  • Immediate post-kidney transplant recipients (initial 3 months following transplant).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AKI risk screening using RenaFAST POCT test kits
All consenting patients will have a real-time biomarker analysis done at 5 time-points during their course of drug therapy using the renaFAST kits.
Diagnostic test: AKI risk screening using RenaFAST POCT test kits

Based on the type and duration of drug therapy, a maximum of 5 time-point urine samples will be collected and real-time biomarker measurement will be done using the RenaFAST POCT kits. Additionally, Trefoil factor 3 (TFF3) biomarker levels will also be quantified using developed POCT kits.

Patients with all 3 biomarker (Clusterin, MCP1 and ß2MG) levels higher than the study cut-off will be identified as high-risk for AKI. The nephrology consultants within the research team will perform a medical chart and physical review (where required) of these patients, detailing potential actions to be taken in research data collection forms. No actual intervention (other than a patient review) will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of an Acute kidney injury (AKI) event
Time Frame: Start date of drug therapy till one week post end date of drug therapy

AKI will be defined by the minimum stage 1 criterion in accordance to KDIGO AKI criteria:

  1. Relative increase in serum creatinine of 1.5 times or higher, versus the baseline.
  2. Absolute increase in serum creatinine of > 26.5 μmol/L within 48 hours.

Additionally, for those administered cisplatin, cases of severe hyponatremia needing hospitalization for severe dehydration and intravenous fluid-rescue will also be taken as an outcome measure of clinically-evident kidney injury and renal salt wasting.

If the subject meets any one of the above 3 criteria, the patient will be recorded as having suffered an AKI event.
Start date of drug therapy till one week post end date of drug therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of AKI event
Time Frame: From the date of AKI onset to date of peak AKI
Peak AKI severity will be determined by highest recorded serum creatinine levels of patient.
From the date of AKI onset to date of peak AKI
Number of AKI days till recovery
Time Frame: From the date of AKI onset to date of resolution of AKI
Number of days from the onset of AKI (as per aforementioned AKI criteria) to resolution of AKI (Defined as when serum creatinine levels reach baseline levels or no longer meet the AKI criterion, whichever is earlier)
From the date of AKI onset to date of resolution of AKI
Length of stay in hospital
Time Frame: From the date of admission to the date of discharge of patient from hospital, assessed up to 12months from date of consent
Duration of hospital stay will be determined based on admission and discharge dates of the patient, for the period relevant to study participation.
From the date of admission to the date of discharge of patient from hospital, assessed up to 12months from date of consent
Number of patients requiring dialysis treatment for the AKI event
Time Frame: From the date of AKI onset to date of resolution of AKI
Whether patient required dialysis/CRRT for treatment of AKI event
From the date of AKI onset to date of resolution of AKI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Collaborators

Agency for Science, Technology and Research

Investigators

  • Principal Investigator: Horng-Ruey Dr Chua, National University Hospital, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 16, 2023

First Submitted That Met QC Criteria

November 6, 2023

First Posted (Estimated)

November 9, 2023

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/00920

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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