Chronic Kidney DiseasesNCT05118074
Nova Max Creatinine and eGFR Meter System
An observational study of Chronic Kidney Diseases and Acute Kidney Injury, run by Nova Biomedical at 3 sites in United States.
Trial summary
To assess the performance of the Nova Max Creatinine and eGFR assay in the hands of CLIA-Waived Point-of-Care users in at least three (3) distinct Point-of-Care clinical settings on venous, and capillary blood and compare the performance characteristics to a traceable laboratory reference method (the Siemens EXL… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Acute Kidney Injury
- What is being tested?
- Creatinine, eGFR
- How many people
- 360 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Jun 2021to 15 Apr 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be identified via medical records for history of CKD or compromised kidney function and contacted to participate in this study. Study site personnel will provide details regarding the study (requirements, test procedure, subject rights) to obtain informed consent from the subject. Potential subjects will be screened using the protocol inclusion and/or exclusion criteria. Adult subjects (≥ 18 years of age) with creatinine levels spanning the entire AMR of the NM Creatinine and eGFR Meter will be recruited for the study.
Who may be able to join
- Adult males or females (≥ 18 years of age)
- CKD Stage 1 (healthy)
- CKD Stages 2-4
- Subjects willing and able to consent to participating in the study.
- Subjects whose pre-screen creatinine and eGFR value, if performed, is deemed valuable to the study.
Who cannot join
- Subjects unable to consent to participating in the study.
- Subjects possessing a cognitive disorder or other condition, which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
South Florida Research Organization
Medley, Florida, 33166
Excellence Medical Research
Miami Gardens, Florida, 33169
Charisma Medical and Research Center
Miami Lakes, Florida, 33014
About this study
Official title: Nova Max Creatinine and eGFR Meter System - Evaluation
To assess the performance of the Nova Max Creatinine and eGFR assay in the hands of CLIA-Waived Point-of-Care users in at least three (3) distinct Point-of-Care clinical settings on venous, and capillary blood and compare the performance characteristics to a traceable laboratory reference method (the Siemens EXL creatinine determination).
To assess the Ease of Use of the Nova Max Creatinine and eGFR Meter System in the hands of the intended CLIA-Waived Point-of-Care users.
Read the detailed description
This study is designed to evaluate the performance of the NM Meter when used by CLIAW operators in terms of both accuracy to an established reference method and precision. CLIAW operators will receive no training or prompting on how to use the NM Creatinine and eGFR Meter, operating only using the instructions found in printed labeling materials (IFU, QRG, packaging).
In determining the accuracy of the device, subjects will be tested using the NM Creatinine and eGFR Meter alongside a central laboratory reference method and the results will be compared to one another. This portion of the study is referred to as Method Comparison.
In determining the precision of the device, multiple creatinine determinations will be made with the NM Creatinine and eGFR meter using both stabilized control materials (testing over the course of 20 days) and venous whole blood specimens (tested over the course of a single day). The difference between the multiple test results will determine the device's level of precision. This portion of the study is referred to as Precision.
- Conditions
- Chronic Kidney Diseases, Acute Kidney Injury
- Being tested
- Creatinine, eGFR
- Keywords
- eGFR, Creatinine, POCT
- Medical subject headings
- Renal Insufficiency, Chronic, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatinine, eGFRDiagnostic test
Compare diagnostic tests to reference methods
What is being measured
The primary outcome is the main question the study is designed to answer.
Analytical verification of Nova Max creatinine and eGFR meter system - Creatinine comparison
Nova Max creatinine and eGFR meter system, a point of care testing instrument is as effective as a reference laboratory method for Creatinine blood results in mg/dL
Measured: 20 days
Analytical verification of Nova Max creatinine and eGFR meter system - eGFR comparison
Nova Max creatinine and eGFR meter system, a point of care testing instrument is as effective as a reference laboratory method for eGFR blood results in mL/min/1.73 m^2
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start8 Jun 2021
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- South Florida Research Organization, Charisma Medical and Research Center, Excellence Medical Research
- Responsible party
- Sponsor
- Investigators
- Giralt Yanez, Principal investigator, South Florida Research OrganizationEduardo Alvarez, Principal investigator, Charisma Medical and Research CenterJeremy Bleicher, Principal investigator, Excellence Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118074
- Sponsor's protocol ID
- NB21-eGFR-NA-FDA
- Status last verified
- Apr 2024
- First submitted
- 28 Jul 2021
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nova Max Creatinine and eGFR Meter System - Evaluation
- ClinicalTrials.gov ID
- NCT05118074
- Acronym / sponsor ID
- NB21-eGFR-NA-FDA
- Conditions
- Chronic Kidney Diseases, Acute Kidney Injury
- Keywords
- eGFR, Creatinine, POCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Nova BiomedicalIndustry (pharma, biotech, devices)
- Collaborators
- South Florida Research Organization, Charisma Medical and Research Center, Excellence Medical Research
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 11 Nov 2021 (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.
To assess the performance of the Nova Max Creatinine and eGFR assay in the hands of CLIA-Waived Point-of-Care users in at least three (3) distinct Point-of-Care clinical settings on venous, and capillary blood and compare the performance characteristics to a traceable laboratory reference method (the Siemens EXL creatinine determination).
To assess the Ease of Use of the Nova Max Creatinine and eGFR Meter System in the hands of the intended CLIA-Waived Point-of-Care users.
Detailed description
This study is designed to evaluate the performance of the NM Meter when used by CLIAW operators in terms of both accuracy to an established reference method and precision. CLIAW operators will receive no training or prompting on how to use the NM Creatinine and eGFR Meter, operating only using the instructions found in printed labeling materials (IFU, QRG, packaging).
In determining the accuracy of the device, subjects will be tested using the NM Creatinine and eGFR Meter alongside a central laboratory reference method and the results will be compared to one another. This portion of the study is referred to as Method Comparison.
In determining the precision of the device, multiple creatinine determinations will be made with the NM Creatinine and eGFR meter using both stabilized control materials (testing over the course of 20 days) and venous whole blood specimens (tested over the course of a single day). The difference between the multiple test results will determine the device's level of precision. This portion of the study is referred to as Precision.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be identified via medical records for history of CKD or compromised kidney function and contacted to participate in this study. Study site personnel will provide details regarding the study (requirements, test procedure, subject rights) to obtain informed consent from the subject. Potential subjects will be screened using the protocol inclusion and/or exclusion criteria. Adult subjects (≥ 18 years of age) with creatinine levels spanning the entire AMR of the NM Creatinine and eGFR Meter will be recruited for the study.
Key inclusion criteria (5 listed)
- Adult males or females (≥ 18 years of age)
- CKD Stage 1 (healthy)
- CKD Stages 2-4
- Subjects willing and able to consent to participating in the study.
- Subjects whose pre-screen creatinine and eGFR value, if performed, is deemed valuable to the study.
Key exclusion criteria (2 listed)
- Subjects unable to consent to participating in the study.
- Subjects possessing a cognitive disorder or other condition, which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study.
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 |
|---|---|---|
| Creatinine, eGFRCompare diagnostic tests to reference methods | Diagnostic test | – |
Primary outcome
Analytical verification of Nova Max creatinine and eGFR meter system - Creatinine comparison
Time frame: 20 days
Nova Max creatinine and eGFR meter system, a point of care testing instrument is as effective as a reference laboratory method for Creatinine blood results in mg/dL
Analytical verification of Nova Max creatinine and eGFR meter system - eGFR comparison
Time frame: 20 days
Nova Max creatinine and eGFR meter system, a point of care testing instrument is as effective as a reference laboratory method for eGFR blood results in mL/min/1.73 m^2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- 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.
Giralt Yanez principal investigator
South Florida Research Organization
Eduardo Alvarez principal investigator
Charisma Medical and Research Center
Jeremy Bleicher principal investigator
Excellence Medical Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Acute Kidney Injury, run by Nova Biomedical at 3 sites in United States.
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 2 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: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analytical verification of Nova Max creatinine and eGFR meter system - Creatinine comparison (time frame: 20 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2025.