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

NCT05321095 | Completed DMC

• 1 other identifier: GPRI-21004-CKD
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

Early detection of kidney disease

Conditions

Chronic Kidney Diseases; Albuminuria

Outcome Measures

Primary Outcomes (1)

• The prevalence of elevated albuminuria

  defined as a confirmed urinary albumin creatinine ratio (UACR) ≥ 3.0 mg/mmol.

  1-2 weeks after invitation

Secondary Outcomes (3)

• The prevalence of unknown elevated albuminuria

  through study completion, an average of 5 weeks

• Average costs per subject

  through study completion, an average of 5 weeks

• the proportion of invited subjects that was identified as having hidden kidney disease

  through study completion, an average of 5 weeks

Study Arms (1)

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.

Diagnostic Test: Albuminuria test; Diagnostic Test: HbA1c test; Diagnostic Test: Creatinine test

Interventions

Albuminuria test DIAGNOSTIC_TEST

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

Also known as: PeeSpot

Screening

HbA1c test DIAGNOSTIC_TEST

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

Also known as: Affinion HbA1c

Screening

Creatinine test DIAGNOSTIC_TEST

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

Also known as: i-STAT Alinity

Screening

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Inability to understand and sign the informed consent form
• Pregnancy

Sponsors & Collaborators

• General Practitioners Research Institute: lead
• University Medical Center Groningen: collaborator

Study Sites (1)

General Practitioners Research Institute

Groningen, 9713GH, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 40247889 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Albuminuria

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Proteinuria; Urination Disorders; Urological Manifestations; Signs and Symptoms

Study Officials

• H.J. Lambers Heerpink, Prof. dr.

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: April 11, 2022
• Study Start: November 25, 2021
• Primary Completion: December 31, 2023
• Study Completion: July 30, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-02

Locations

NL (1)