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

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.

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.

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).