Acute Kidney InjuryRenaFASTNCT06124885
Real-time Early Detection of Nephrotoxicity by Urinary Biomarker Analysis With SeroFlow Technology
A study testing AKI risk screening using RenaFAST POCT test kits in people with Acute Kidney Injury, run by National University Hospital, Singapore at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- AKI risk screening using RenaFAST POCT test kits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSingapore
- Study dates
- Nov 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore
Horng Ruey Chua, horng_ruey_chua@nuhs.edu.sg
Horng Ruey Chua
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Kidney Injury
- Being tested
- AKI risk screening using RenaFAST POCT test kits
- Keywords
- Nephrotoxicity, Urinary biomarkers, Clusterin, monocyte chemoattractant protein-1 (MCP1), Beta-2 microglobulin (ß2MG), Anti-microbials, Calcineurin inhibitors
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKI risk screening using RenaFAST POCT test kitsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: AKI risk screening using RenaFAST POCT test kits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Start date of drug therapy till one week post end date of drug therapy
Secondary outcomes (4)
Severity of AKI event
Peak AKI severity will be determined by highest recorded serum creatinine levels of patient.
Measured: From the date of AKI onset to date of peak AKI
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)
Measured: From the date of AKI onset to date of resolution of AKI
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.
Measured: 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
Whether patient required dialysis/CRRT for treatment of AKI event
Measured: From the date of AKI onset to date of resolution of AKI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study startNov 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm design. All eligible and consenting patients will have their time-point urine samples collected and biomarker levels measured.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Science, Technology and Research
- Responsible party
- Sponsor
- Investigators
- Horng-Ruey Dr Chua, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124885
- Sponsor's protocol ID
- 2021/00920
- Acronym
- RenaFAST
- Status last verified
- Jun 2023
- First submitted
- 16 Oct 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31296157
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Early Detection of Nephrotoxicity by Accurate and Faster Urinary Biomarker Analysis With SeroFlow Technology (RenaFAST Study)
- ClinicalTrials.gov ID
- NCT06124885
- Acronym / sponsor ID
- RenaFAST / 2021/00920
- Conditions
- Acute Kidney Injury
- Keywords
- Nephrotoxicity, Urinary biomarkers, Clusterin, monocyte chemoattractant protein-1 (MCP1), Beta-2 microglobulin (ß2MG), Anti-microbials, Calcineurin inhibitors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Agency for Science, Technology and Research
- Study start
- Nov 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm design. All eligible and consenting patients will have their time-point urine samples collected and biomarker levels measured.
| Arm | Type | Receives |
|---|---|---|
| AKI risk screening using RenaFAST POCT test kits | Experimental | Diagnostic Test: AKI risk screening using RenaFAST POCT test kitsAll consenting patients will have a real-time biomarker analysis done at 5 time-points during their course of drug therapy using the renaFAST kits. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AKI risk screening using RenaFAST POCT test kitsBased 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. | Diagnostic test | AKI risk screening using RenaFAST POCT test kits |
Primary outcome
Presence of an Acute kidney injury (AKI) event
Time frame: Start date of drug therapy till one week post end date of drug therapy
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.
4 secondary outcomes
Severity of AKI event
Time frame: From the date of AKI onset to date of peak AKI
Number of AKI days till recovery
Time frame: From the date of AKI onset to date of resolution of AKI
Length of stay in hospital
Time frame: 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
Time frame: From the date of AKI onset to date of resolution of AKI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Background: PubMed 31296157Da 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Horng-Ruey Dr Chua principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AKI risk screening using RenaFAST POCT test kits in people with Acute Kidney Injury, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Horng-Ruey Dr Chua (67722544, horng_ruey_chua@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of an Acute kidney injury (AKI) event (time frame: Start date of drug therapy till one week post end date of drug therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06124885, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.