Chronic Kidney DiseasesSALINENCT05321095
Screening for Albuminuria at the First Line for Early Identification of CKD
An observational study of Chronic Kidney Diseases and Albuminuria, run by General Practitioners Research Institute at 1 site in Netherlands.
Trial summary
Early detection of kidney disease Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Diseases, Albuminuria
- What is being tested?
- Albuminuria test, HbA1c test and Creatinine test
- How many people
- 141 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Nov 2021to 30 Jul 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with a high risk of (developing) chronic kidney disease will be recruited in primary care practices and pharmacies from the General Practitioners Research Institute (GPRI) network. The organizational model of GPRI is based on the participation of independent practices and pharmacies in the Netherlands, well-trained GPs, pharmacists and their staff. Male and female subjects aged above 18 years that meet the inclusion criteria will be eligible for the study.
Who may be able to join
- Diabetes Mellitus (diagnosis or prescription for the disease based on the NHG guidelines)
- Adipositas (diagnosis)
- Hypertension (diagnosis or prescription for the disease based on the NHG guidelines)
- Cardiovascular disease (diagnosis, specified in protocol section 5.2.2)
- Lipid disorder (diagnosis or prescription for the disease based on the NHG guidelines)
Who cannot join
- Inability to understand and sign the informed consent form
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
General Practitioners Research Institute
Groningen, 9713GH
About this study
Official title: Screening for Albuminuria at the First Line for Early Identification of Chronic Kidney Disease: a Pilot Study
Early detection of kidney disease
Read the detailed description
Early detection and appropriate treatment of kidney disease is important as this may prevent future cardiovascular complications and end-organ damage more effectively than intervention in more advanced stages of disease. There is a well-established relationship between albuminuria and renal- and cardiovascular disease. Elevated albuminuria has a relatively high prevalence in the general population (5-9%). The prevalence of albuminuria is even higher in high-risk patients with diabetes Mellitus, hypertension, obesity, cardiovascular disease and lipid disorders. Adequate treatment of albuminuria, preferable at early stages can prevent both cardiovascular and renal disease progression. However, scarce epidemiological data show that albuminuria measurements are only conducted in a minority of individuals and disease recognition is suboptimal, even in high-risk groups. The current study aims to evaluate if and how early identification of chronic kidney disease by targeted screening of albuminuria levels is feasible in primary care (pharmacies and general practitioners) to optimally discover and treat patients with elevated albuminuria.
- Conditions
- Chronic Kidney Diseases, Albuminuria
- Being tested
- Albuminuria test, HbA1c test, Creatinine test
- Medical subject headings
- Renal Insufficiency, Chronic, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albuminuria testDiagnostic test
Also called PeeSpot
During participation, subjects are asked to collect one or more urine samples for albuminuria determination.
HbA1c testDiagnostic test
Also called Affinion HbA1c
During the screening visit, HbA1c will be measured with a point-of-care test (Affinion HbA1c, Abbott).
Creatinine testDiagnostic test
Also called i-STAT Alinity
During the screening visit, creatinine will be measured with a point-of-care test (i-STAT Alinity handheld analyser, Abbott).
| Study group | Role | What they receive |
|---|---|---|
| Screening | Only one group will be evaluated during the SALINE study. Everyone that meets the inclusion criteria of having a high risk for albuminuria is invited to participate. During participation, subjects are asked to collect one or more urine samples for albuminuria determination. If albuminuria is high (>= 3,0 mg/mmol) subjects are invited for a visit. During the visit non-invasive measurements (BMI, PoC HbA1c, eGFR, blood pressure and heart rate) are taken to determine the cardiovascular risk. Furthermore, medication use is reviewed. Receives: Diagnostic Test: Albuminuria test; Diagnostic Test: HbA1c test; Diagnostic Test: Creatinine test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of elevated albuminuria
defined as a confirmed urinary albumin creatinine ratio (UACR) ≥ 3.0 mg/mmol.
Measured: 1-2 weeks after invitation
Secondary outcomes (3)
The prevalence of unknown elevated albuminuria
defined as elevated albuminuria not reported by the subject or previously recorded in electronic medical records of the subjects' general practice or pharmacy.
Measured: through study completion, an average of 5 weeks
Average costs per subject
by screening for albuminuria via pharmacies versus general practitioners.
Measured: through study completion, an average of 5 weeks
the proportion of invited subjects that was identified as having hidden kidney disease
by screening for albuminuria via pharmacies versus general practitioners.
Measured: through study completion, an average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start25 Nov 2021
- Primary completion31 Dec 2023
- Study completion30 Jul 2024
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 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Practitioners Research Institute
- Sponsor type
- Research network
- Collaborators
- University Medical Center Groningen
- Responsible party
- Sponsor
- Investigators
- H.J. Lambers Heerpink, Prof. dr., Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321095
- Sponsor's protocol ID
- GPRI-21004-CKD
- Acronym
- SALINE
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2022
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van Mil D, Kieneker LM, Harms E, Prins GH, van Geer-Postmus I, Mepschen M, Leving MT, Stoker N, Herman Kocks JW, Gansevoort RT, Lambers Heerspink HJ. Effectiveness of a systematic home-based albuminuria screening programme to detect chronic kidney disease in high-risk individuals in primary care (SALINE): a cross-sectional screening study. EClinicalMedicine. 2025 Apr 8;82:103185. doi: 10.1016/j.eclinm.2025.103185. eCollection 2025 Apr.
PubMed 40247889
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Albuminuria at the First Line for Early Identification of Chronic Kidney Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT05321095
- Acronym / sponsor ID
- SALINE / GPRI-21004-CKD
- Conditions
- Chronic Kidney Diseases, Albuminuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- General Practitioners Research InstituteResearch network
- Collaborators
- University Medical Center Groningen
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 11 Apr 2022 (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.
Early detection of kidney disease
Detailed description
Early detection and appropriate treatment of kidney disease is important as this may prevent future cardiovascular complications and end-organ damage more effectively than intervention in more advanced stages of disease. There is a well-established relationship between albuminuria and renal- and cardiovascular disease. Elevated albuminuria has a relatively high prevalence in the general population (5-9%). The prevalence of albuminuria is even higher in high-risk patients with diabetes Mellitus, hypertension, obesity, cardiovascular disease and lipid disorders. Adequate treatment of albuminuria, preferable at early stages can prevent both cardiovascular and renal disease progression. However, scarce epidemiological data show that albuminuria measurements are only conducted in a minority of individuals and disease recognition is suboptimal, even in high-risk groups. The current study aims to evaluate if and how early identification of chronic kidney disease by targeted screening of albuminuria levels is feasible in primary care (pharmacies and general practitioners) to optimally discover and treat patients with elevated albuminuria.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening | – | Diagnostic Test: Albuminuria test, Diagnostic Test: HbA1c test, Diagnostic Test: Creatinine testOnly one group will be evaluated during the SALINE study. Everyone that meets the inclusion criteria of having a high risk for albuminuria is invited to participate. During participation, subjects are asked to collect one or more urine samples for albuminuria determination. If albuminuria is high (>= 3,0 mg/mmol) subjects are invited for a visit. During the visit non-invasive measurements (BMI, PoC HbA1c, eGFR, blood pressure and heart rate) are taken to determine the cardiovascular risk. Furthermore, medication use is reviewed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with a high risk of (developing) chronic kidney disease will be recruited in primary care practices and pharmacies from the General Practitioners Research Institute (GPRI) network. The organizational model of GPRI is based on the participation of independent practices and pharmacies in the Netherlands, well-trained GPs, pharmacists and their staff. Male and female subjects aged above 18 years that meet the inclusion criteria will be eligible for the study.
Key inclusion criteria (5 listed)
- Diabetes Mellitus (diagnosis or prescription for the disease based on the NHG guidelines)
- Adipositas (diagnosis)
- Hypertension (diagnosis or prescription for the disease based on the NHG guidelines)
- Cardiovascular disease (diagnosis, specified in protocol section 5.2.2)
- Lipid disorder (diagnosis or prescription for the disease based on the NHG guidelines)
Key exclusion criteria (2 listed)
- Inability to understand and sign the informed consent form
- Pregnancy
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 |
|---|---|---|
| Albuminuria testAlso: PeeSpotDuring participation, subjects are asked to collect one or more urine samples for albuminuria determination. | Diagnostic test | Screening |
| HbA1c testAlso: Affinion HbA1cDuring the screening visit, HbA1c will be measured with a point-of-care test (Affinion HbA1c, Abbott). | Diagnostic test | Screening |
| Creatinine testAlso: i-STAT AlinityDuring the screening visit, creatinine will be measured with a point-of-care test (i-STAT Alinity handheld analyser, Abbott). | Diagnostic test | Screening |
Primary outcome
The prevalence of elevated albuminuria
Time frame: 1-2 weeks after invitation
defined as a confirmed urinary albumin creatinine ratio (UACR) ≥ 3.0 mg/mmol.
3 secondary outcomes
The prevalence of unknown elevated albuminuria
Time frame: through study completion, an average of 5 weeks
Average costs per subject
Time frame: through study completion, an average of 5 weeks
the proportion of invited subjects that was identified as having hidden kidney disease
Time frame: through study completion, an average of 5 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 9 Aug 2024.
- Derived from this study: PubMed 40247889van Mil D, Kieneker LM, Harms E, Prins GH, van Geer-Postmus I, Mepschen M, Leving MT, Stoker N, Herman Kocks JW, Gansevoort RT, Lambers Heerspink HJ. Effectiveness of a systematic home-based albuminuria screening programme to detect chronic kidney disease in high-risk individuals in primary care (SALINE): a cross-sectional screening study. EClinicalMedicine. 2025 Apr 8;82:103185. doi: 10.1016/j.eclinm.2025.103185. eCollection 2025 Apr.
- Individual participant dataSharing planned: Undecided
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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.
H.J. Lambers Heerpink, Prof. dr. principal investigator
University Medical Center Groningen
1 site 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 Albuminuria, run by General Practitioners Research Institute at 1 site in Netherlands.
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 9 Aug 2024. 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 Netherlands. 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?
The prevalence of elevated albuminuria (time frame: 1-2 weeks after invitation). 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 NCT05321095, 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 Aug 2024.