Screening for Albuminuria at the First Line for Early Identification of CKD (SALINE)

Screening for Albuminuria at the First Line for Early Identification of Chronic Kidney Disease: a Pilot Study

Early detection of kidney disease

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases; Albuminuria
• Intervention / Treatment: Diagnostic test: Albuminuria test; Diagnostic test: HbA1c test; Diagnostic test: Creatinine test

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 Type: Observational
• Enrollment (Actual): 141

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713GH
    • General Practitioners Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; During participation, subjects are asked to collect one or more urine samples for albuminuria determination.; Other Names: PeeSpot; Diagnostic test: HbA1c test; During the screening visit, HbA1c will be measured with a point-of-care test (Affinion HbA1c, Abbott).; Other Names: 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 Names: i-STAT Alinity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The prevalence of elevated albuminuria	defined as a confirmed urinary albumin creatinine ratio (UACR) ≥ 3.0 mg/mmol.	1-2 weeks after invitation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	through study completion, an average of 5 weeks
Average costs per subject	by screening for albuminuria via pharmacies versus general practitioners.	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.	through study completion, an average of 5 weeks

Collaborators and Investigators

• Sponsor: General Practitioners Research Institute
• Collaborators: University Medical Center Groningen
• Investigators: Principal Investigator: H.J. Lambers Heerpink, Prof. dr., UMCG

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urological Manifestations; Disease Attributes; Renal Insufficiency; Urination Disorders; Proteinuria; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Albuminuria
• Other Study ID Numbers: GPRI-21004-CKD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No