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

NCT06124885 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-11-09

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Agency for Science, Technology and Research

    collaborator OTHER

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Horng-Ruey Dr Chua · National University Hospital, Singapore

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2024-10-31
Completion
2024-12-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06124885 on ClinicalTrials.gov