Real-time detection of kidney injury using urinary biomarkers
Real-time Early Detection of Nephrotoxicity by Accurate and Faster Urinary Biomarker Analysis With SeroFlow Technology (RenaFAST Study)
This study is testing a new urine test to see if it can help doctors spot kidney injury early in patients receiving certain medications that can harm the kidneys.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | National University Hospital, Singapore Academic / other |
| Drugs / interventions | Chemotherapy, Immunotherapy, Methotrexate |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06124885 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the RenaFAST kit, a point-of-care test that quantifies three urinary proteins, to predict acute kidney injury (AKI) in patients undergoing nephrotoxic drug therapies. Eligible patients will provide up to five urine samples, which will be analyzed in real-time for biomarkers such as Clusterin, MCP1, and Beta-2 microglobulin. The study will identify patients at high risk for AKI and evaluate potential interventions based on early predictions. The nephrology team will review patient data to assess the effectiveness of the biomarker analysis in guiding clinical decisions.
Who should consider this trial
Good fit: Ideal candidates include patients receiving prolonged therapy with nephrotoxic medications such as certain antimicrobials, calcineurin inhibitors, antivirals, or anti-cancer drugs.
Not a fit: Patients with pre-existing acute kidney injury, severely reduced kidney function, or those in critical care settings may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enable earlier detection and intervention for acute kidney injury, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using urinary biomarkers for early detection of kidney injury, suggesting this approach has potential based on previous findings.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Singapore
- National University Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Horng-Ruey Dr Chua — National University Hospital, Singapore
- Study coordinator: Horng-Ruey Dr Chua
- Email: horng_ruey_chua@nuhs.edu.sg
- Phone: 67722544
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.