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

NCT06124885 | Unknown DMC

• 1 other identifier: 2021/00920
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Acute Kidney Injury

Keywords

Nephrotoxicity; Urinary biomarkers; Clusterin; monocyte chemoattractant protein-1 (MCP1); Beta-2 microglobulin (ß2MG); Anti-microbials; Calcineurin inhibitors

Outcome Measures

Primary Outcomes (1)

• Presence of an Acute kidney injury (AKI) event

  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 Outcomes (4)

• Severity of AKI event

  From the date of AKI onset to date of peak AKI

• Number of AKI days till recovery

  From the date of AKI onset to date of resolution of AKI

• Length of stay in hospital

  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

  From the date of AKI onset to date of resolution of AKI

Study Arms (1)

AKI risk screening using RenaFAST POCT test kits

EXPERIMENTAL

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

Interventions

AKI risk screening using RenaFAST POCT test kits DIAGNOSTIC_TEST

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.

AKI risk screening using RenaFAST POCT test kits

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Agency for Science, Technology and Research: collaborator

Study Sites (1)

National University Hospital

Singapore, Singapore

RECRUITING

Related Publications (1)

• Da Y, Akalya K, Murali T, Vathsala A, Tan CS, Low S, Lim HN, Teo BW, Lau T, Ong L, Chua HR. Serial Quantification of Urinary Protein Biomarkers to Predict Drug-induced Acute Kidney Injury. Curr Drug Metab. 2019;20(8):656-664. doi: 10.2174/1389200220666190711114504.

  PMID: 31296157 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Horng-Ruey Dr Chua

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Horng-Ruey Dr Chua

CONTACT

67722544; horng_ruey_chua@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm design. All eligible and consenting patients will have their time-point urine samples collected and biomarker levels measured.

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: November 9, 2023
• Study Start: November 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)