Clinical trial NCT06124885: Real-time Early Detection of Nephrotoxicity by Urinary Biomarker Analysis With SeroFlow Technology
Official title: Real-time Early Detection of Nephrotoxicity by Accurate and Faster Urinary Biomarker Analysis With SeroFlow Technology (RenaFAST Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Nephrotoxicity
Urinary biomarkers
Clusterin
monocyte chemoattractant protein-1 (MCP1)
Beta-2 microglobulin (ß2MG)
Anti-microbials
Calcineurin inhibitors
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: Agency for Science, Technology and Research
First posted: 2023-11-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm design. All eligible and consenting patients will have their time-point urine samples collected and biomarker levels measured.
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Presence of an Acute kidney injury (AKI) event
timeFrame: Start date of drug therapy till one week post end date of drug therapy
Secondary outcomes:
measure: Severity of AKI event
timeFrame: From the date of AKI onset to date of peak AKI
measure: Number of AKI days till recovery
timeFrame: From the date of AKI onset to date of resolution of AKI
measure: Length of stay in hospital
timeFrame: From the date of admission to the date of discharge of patient from hospital, assessed up to 12months from date of consent
measure: Number of patients requiring dialysis treatment for the AKI event
timeFrame: From the date of AKI onset to date of resolution of AKI
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Horng-Ruey Dr Chua
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.