Screening for Albuminuria at the First Line for Early Identification of CKD (SALINE)
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| ClinicalTrials.gov Identifier: NCT05321095 |
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Recruitment Status :
Recruiting
First Posted : April 11, 2022
Last Update Posted : May 5, 2022
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Sponsor:
University Medical Center Groningen
Collaborator:
General Practitioners Research Institute
Information provided by (Responsible Party):
University Medical Center Groningen
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Brief Summary:
Early detection of kidney disease
| Condition or disease | Intervention/treatment |
|---|---|
| Chronic Kidney Diseases Albuminuria | Diagnostic Test: Albuminuria test Diagnostic Test: HbA1c test Diagnostic Test: Creatinine test |
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 Type : | Observational |
| Estimated Enrollment : | 110 participants |
| Observational Model: | Other |
| Time Perspective: | Cross-Sectional |
| Official Title: | Screening for Albuminuria at the First Line for Early Identification of Chronic Kidney Disease: a Pilot Study |
| Actual Study Start Date : | November 25, 2021 |
| Estimated Primary Completion Date : | June 2022 |
| Estimated Study Completion Date : | June 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Kidney Diseases
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Diagnostic Test: Albuminuria test
During participation, subjects are asked to collect one or more urine samples for albuminuria determination.
Other Name: PeeSpot Diagnostic Test: HbA1c test During the screening visit, HbA1c will be measured with a point-of-care test (Affinion HbA1c, Abbott).
Other Name: Affinion HbA1c Diagnostic Test: Creatinine test During the screening visit, creatinine will be measured with a point-of-care test (i-STAT Alinity handheld analyser, Abbott).
Other Name: i-STAT Alinity |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- The prevalence of unknown elevated albuminuria [ Time Frame: through study completion, an average of 5 weeks ]defined as elevated albuminuria not reported by the subject or previously recorded in electronic medical records of the subjects' general practice or pharmacy.
- Average costs per subject [ Time Frame: through study completion, an average of 5 weeks ]by screening for albuminuria via pharmacies versus general practitioners.
- the proportion of invited subjects that was identified as having hidden kidney disease [ Time Frame: through study completion, an average of 5 weeks ]by screening for albuminuria via pharmacies versus general practitioners.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Inability to understand and sign the informed consent form
- Pregnancy
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05321095
Contacts
| Contact: M. Kerkhof, MD PhD | 050-2113898 ext 31 | saline-studie@gpri.nl | |
| Contact: H.J. Lambers Heerspink, Prof. dr. | 050-3617859 ext 31 | h.j.lambers.heerspink@umcg.nl |
Locations
| Netherlands | |
| General Practitioners Research Institute | Recruiting |
| Groningen, Netherlands, 9713GH | |
| Contact: J.W.H. Kocks, Prof. dr. MD +31502113898 saline-studie@gpri.nl | |
Sponsors and Collaborators
University Medical Center Groningen
General Practitioners Research Institute
Investigators
| Principal Investigator: | H.J. Lambers Heerpink, Prof. dr. | UMCG |
| Responsible Party: | University Medical Center Groningen |
| ClinicalTrials.gov Identifier: | NCT05321095 |
| Other Study ID Numbers: |
GPRI-21004-CKD |
| First Posted: | April 11, 2022 Key Record Dates |
| Last Update Posted: | May 5, 2022 |
| Last Verified: | April 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Kidney Diseases Renal Insufficiency, Chronic Albuminuria Urologic Diseases |
Renal Insufficiency Proteinuria Urination Disorders Urological Manifestations |