Screening for Albuminuria at the First Line for Early Identification of CKD

NCT ID: NCT05321095

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 141 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-25
• Study Completion Date: 2024-07-30

Brief Summary

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.

Conditions

Chronic Kidney Diseases; Albuminuria

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Albuminuria test

Intervention Type: DIAGNOSTIC_TEST

During participation, subjects are asked to collect one or more urine samples for albuminuria determination.

HbA1c test

Intervention Type: DIAGNOSTIC_TEST

During the screening visit, HbA1c will be measured with a point-of-care test (Affinion HbA1c, Abbott).

Creatinine test

Intervention Type: DIAGNOSTIC_TEST

During the screening visit, creatinine will be measured with a point-of-care test (i-STAT Alinity handheld analyser, Abbott).

Interventions

Albuminuria test

During participation, subjects are asked to collect one or more urine samples for albuminuria determination.

Intervention Type: DIAGNOSTIC_TEST

HbA1c test

During the screening visit, HbA1c will be measured with a point-of-care test (Affinion HbA1c, Abbott).

Intervention Type: DIAGNOSTIC_TEST

Creatinine test

During the screening visit, creatinine will be measured with a point-of-care test (i-STAT Alinity handheld analyser, Abbott).

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

PeeSpot; Affinion HbA1c; i-STAT Alinity

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: collaborator

General Practitioners Research Institute

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

H.J. Lambers Heerpink, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

UMCG

Locations

General Practitioners Research Institute

Groningen, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 40247889 (View on PubMed)

Other Identifiers

GPRI-21004-CKD

Identifier Type: -

Identifier Source: org_study_id