Kidney TransplantNCT07392710
Clinical Evaluation of the Nova Max Pro StatSensor Device
A study testing Nova Max Pro StatSensor device in people with Kidney Transplant and Kidney Disease, Chronic, run by Royal Free Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Blood creatinine is an important biomarker used to monitor kidney function. In patients with chronic kidney disease or patients who have received a kidney transplant, careful and frequent monitoring of kidney function is required to enable timely intervention in the event of deteriorating kidney function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant, Kidney Disease, Chronic
- What is being tested?
- Nova Max Pro StatSensor device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Feb 2023to 12 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18-year-old
- Able to provide informed consent
- Receipt of a renal transplant
- Attending the renal transplant clinic and the study site.
- Sub-study only: Demonstrate proficiency in using the Nova Max Pro device correctly at Screening (V1) or Visit 3, if enrolling in sub-study at later date.
Who cannot join
- Declined written informed consent
- Pregnant females or females who plan to conceive during the 12-week study period.
- History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational device, put the subject at risk, influence the subject's ability to participate or affect the interpretation of the results of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Nova Max Pro Statsensor Point of Care Creatinine Measuring Device in the Clinical Outpatient and Home Setting & Assessment of the Patient Experience
Blood creatinine is an important biomarker used to monitor kidney function. In patients with chronic kidney disease or patients who have received a kidney transplant, careful and frequent monitoring of kidney function is required to enable timely intervention in the event of deteriorating kidney function. Indeed, following kidney transplantation, patients may have their blood serum creatinine checked on average 20 times, during the first year post-transplantation to monitor for graft rejection.
In current clinical practice, most blood creatinine assessments (blood tests) are undertaken in the primary care GP clinics or hospital settings. This practice places burden on healthcare resources and may delay the early detection of deteriorating kidney function. It also places additional burden on patients and impact's their lives as patients are required to attend frequent clinic appointments and undertake regular blood tests. Therefore, the ability for individuals to remotely self-monitor their own kidney function would have a number of health and socio-economic related benefits.
Currently the study will evaluate the clinical usefulness and reliability of a handheld point of care creatinine monitoring device called the Nova Max Pro StatSensor device, in patients who have recently received a kidney transplant. The aim is to compare the clinical performance (i.e accuracy and precision) of the device, with standard laboratory based measurements for measuring blood creatinine levels, in 100 transplant patients attending the outpatient clinic. All patients will be enrolled in the study for a period of 12-weeks. As part of the nested sub-study, 30 participants will measuring their creatinine levels using the Nova Max Pro StatSensor device at home, on the morning of their outpatient clinic. the study will assess the patients experience and attitude towards using the device via a questionnaire and structured interview at the end of the study.
- Conditions
- Kidney Transplant, Kidney Disease, Chronic
- Being tested
- Nova Max Pro StatSensor device
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nova Max Pro StatSensor deviceDevice
The Nova Max Pro StatSensor creatinine analyser is a handheld device used for the quantitative measurement of creatinine in capillary, venous and arterial blood. This study will evaluate the Nova Max Pro in the outpatient setting to ascertain whether the device can be used to reliably monitor renal function remotely post-transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Main study | Other | Assessment of capillary blood creatine levels, using the Nova Max Pro device, at the participating site, on the day of the patient's routine outpatient clinic visit and in the remote setting. Receives: Device: Nova Max Pro StatSensor device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficient of variation (CV) calculated from repeated creatinine measures taken from the Nova Max Pro creatinine analyser and reference laboratory method over the duration of the study
Measured: Up to 12 weeks
Mean measurements & standard deviation of repeated creatinine measures taken from the Nova Max Pro creatinine analyser and reference laboratory method over the duration of the study
Measured: Up to 12 weeks
A structured questionnaire undertaken at the end of the study will assess subjects' satisfaction and attitudes towards creatinine self-monitoring with the Nova Max Pro creatinine analyser.
Measured: Up to 12 weeks
A structured interview undertaken at the end of the study will assess subjects' satisfaction and attitudes towards creatinine self-monitoring with the Nova Max Pro creatinine analyser.
Measured: Up to 12 weeks
Secondary outcomes (4)
Coefficient of variation calculated from repeated creatinine measures taken from the Nova Max Pro creatinine analyser and local laboratory over the study period. Results from outpatient and remote settings will be analysed together and separately.
Measured: Up to 12 weeks
Mean measurements & standard deviation of repeated creatinine measures taken from the Nova Max Pro device and reference laboratory method over the duration of the study
Measured: Up to 12 weeks
Assessed by determining the concordance correlation coefficient for Nova Max Pro creatinine analyser compared with measurements obtained by the laboratory reference methods. Measurements obtained in outpatient and remote settings will be analysed
Measured: Up to 12 weeks
R2 and Intraclass correlation coefficient (ICC) for repeated measurements from the Nova Max Pro creatinine analyser.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start2 Feb 2023
- Primary completion12 Dec 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The 12-week study involves up to six visits aligned with routine outpatient appointments (about every two weeks). A total of 100 subjects will join the main study, with 30 also participating in a nested sub-study. Subjects are identified during transplant clinic visits and, after written consent, assigned a unique study code accessible only to the research team. As part of standard care, patients have venous blood drawn weekly or fortnightly; the study adds one extra 2ml sample at the same time, totalling up to six samples. At each visit, two capillary samples (finger prick) will be taken using the Nova Max Pro StatSensor device, operated by trained staff, with results recorded in the eCRF. Sub-study participants will use the device at home to measure creatinine within 24 hours of clinic visits (five times), bringing the device to appointments for data retrieval. At the final visit, they will complete a usability survey and a 45-minute interview about their experience.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Free Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Mark Harber, Dr, Principal investigator, Royal Free London NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392710
- Sponsor's protocol ID
- 22/NW/0323
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share IPD as it will not add any value to publication
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Nova Max Pro Statsensor Point of Care Creatinine Measuring Device in the Clinical Outpatient and Home Setting & Assessment of the Patient Experience
- ClinicalTrials.gov ID
- NCT07392710
- Acronym / sponsor ID
- 22/NW/0323
- Conditions
- Kidney Transplant, Kidney Disease, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Royal Free Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 6 Feb 2026 (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.
Blood creatinine is an important biomarker used to monitor kidney function. In patients with chronic kidney disease or patients who have received a kidney transplant, careful and frequent monitoring of kidney function is required to enable timely intervention in the event of deteriorating kidney function. Indeed, following kidney transplantation, patients may have their blood serum creatinine checked on average 20 times, during the first year post-transplantation to monitor for graft rejection.
In current clinical practice, most blood creatinine assessments (blood tests) are undertaken in the primary care GP clinics or hospital settings. This practice places burden on healthcare resources and may delay the early detection of deteriorating kidney function. It also places additional burden on patients and impact's their lives as patients are required to attend frequent clinic appointments and undertake regular blood tests. Therefore, the ability for individuals to remotely self-monitor their own kidney function would have a number of health and socio-economic related benefits.
Currently the study will evaluate the clinical usefulness and reliability of a handheld point of care creatinine monitoring device called the Nova Max Pro StatSensor device, in patients who have recently received a kidney transplant. The aim is to compare the clinical performance (i.e accuracy and precision) of the device, with standard laboratory based measurements for measuring blood creatinine levels, in 100 transplant patients attending the outpatient clinic. All patients will be enrolled in the study for a period of 12-weeks. As part of the nested sub-study, 30 participants will measuring their creatinine levels using the Nova Max Pro StatSensor device at home, on the morning of their outpatient clinic. the study will assess the patients experience and attitude towards using the device via a questionnaire and structured interview at the end of the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The 12-week study involves up to six visits aligned with routine outpatient appointments (about every two weeks). A total of 100 subjects will join the main study, with 30 also participating in a nested sub-study. Subjects are identified during transplant clinic visits and, after written consent, assigned a unique study code accessible only to the research team. As part of standard care, patients have venous blood drawn weekly or fortnightly; the study adds one extra 2ml sample at the same time, totalling up to six samples. At each visit, two capillary samples (finger prick) will be taken using the Nova Max Pro StatSensor device, operated by trained staff, with results recorded in the eCRF. Sub-study participants will use the device at home to measure creatinine within 24 hours of clinic visits (five times), bringing the device to appointments for data retrieval. At the final visit, they will complete a usability survey and a 45-minute interview about their experience.
| Arm | Type | Receives |
|---|---|---|
| Main study | Other | Device: Nova Max Pro StatSensor deviceAssessment of capillary blood creatine levels, using the Nova Max Pro device, at the participating site, on the day of the patient's routine outpatient clinic visit and in the remote setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18-year-old
- Able to provide informed consent
- Receipt of a renal transplant
- Attending the renal transplant clinic and the study site.
- Sub-study only: Demonstrate proficiency in using the Nova Max Pro device correctly at Screening (V1) or Visit 3, if enrolling in sub-study at later date.
Key exclusion criteria (3 listed)
- Declined written informed consent
- Pregnant females or females who plan to conceive during the 12-week study period.
- History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational device, put the subject at risk, influence the subject's ability to participate or affect the interpretation of the results 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 |
|---|---|---|
| Nova Max Pro StatSensor deviceThe Nova Max Pro StatSensor creatinine analyser is a handheld device used for the quantitative measurement of creatinine in capillary, venous and arterial blood. This study will evaluate the Nova Max Pro in the outpatient setting to ascertain whether the device can be used to reliably monitor renal function remotely post-transplantation. | Device | Main study |
Primary outcome
Coefficient of variation (CV) calculated from repeated creatinine measures taken from the Nova Max Pro creatinine analyser and reference laboratory method over the duration of the study
Time frame: Up to 12 weeks
Mean measurements & standard deviation of repeated creatinine measures taken from the Nova Max Pro creatinine analyser and reference laboratory method over the duration of the study
Time frame: Up to 12 weeks
A structured questionnaire undertaken at the end of the study will assess subjects' satisfaction and attitudes towards creatinine self-monitoring with the Nova Max Pro creatinine analyser.
Time frame: Up to 12 weeks
A structured interview undertaken at the end of the study will assess subjects' satisfaction and attitudes towards creatinine self-monitoring with the Nova Max Pro creatinine analyser.
Time frame: Up to 12 weeks
4 secondary outcomes
Coefficient of variation calculated from repeated creatinine measures taken from the Nova Max Pro creatinine analyser and local laboratory over the study period. Results from outpatient and remote settings will be analysed together and separately.
Time frame: Up to 12 weeks
Mean measurements & standard deviation of repeated creatinine measures taken from the Nova Max Pro device and reference laboratory method over the duration of the study
Time frame: Up to 12 weeks
Assessed by determining the concordance correlation coefficient for Nova Max Pro creatinine analyser compared with measurements obtained by the laboratory reference methods. Measurements obtained in outpatient and remote settings will be analysed
Time frame: Up to 12 weeks
R2 and Intraclass correlation coefficient (ICC) for repeated measurements from the Nova Max Pro creatinine analyser.
Time frame: Up to 12 weeks
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 6 Feb 2026.
- Individual participant dataSharing planned: No. There are no plans to share IPD as it will not add any value to publication
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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.
Mark Harber, Dr principal investigator
Royal Free London NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nova Max Pro StatSensor device in people with Kidney Transplant and Kidney Disease, Chronic, run by Royal Free Hospital NHS Foundation Trust at 1 site in United Kingdom.
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 3 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 6 Feb 2026. 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 United Kingdom. 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?
Coefficient of variation (CV) calculated from repeated creatinine measures taken from the Nova Max Pro creatinine analyser and reference laboratory method over the duration of the study (time frame: Up to 12 weeks). The study lists 4 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 6 Feb 2026.