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

Acute Kidney Injury Clinical Trial

— RenaFAST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06124885
• Other study ID #: 2021/00920
• Status: Recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: National University Hospital, Singapore
• Contact: Horng-Ruey Dr Chua
• Phone: 67722544
• Email: horng_ruey_chua[@]nuhs.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

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.

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	Agency for Science, Technology and Research

Country where clinical trial is conducted

Singapore, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of an Acute kidney injury (AKI) event	AKI will be defined by the minimum stage 1 criterion in accordance to KDIGO AKI criteria: Relative increase in serum creatinine of 1.5 times or higher, versus the baseline.; 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	Severity of AKI event	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
Secondary	Number of AKI days till recovery	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
Secondary	Length of stay in hospital	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
Secondary	Number of patients requiring dialysis treatment for the AKI event	Whether patient required dialysis/CRRT for treatment of AKI event	From the date of AKI onset to date of resolution of AKI