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

Chronic Kidney Diseases Clinical Trial

— SALINE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05321095
• Other study ID #: GPRI-21004-CKD
• Status: Active, not recruiting
• Start date: November 25, 2021
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: General Practitioners Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Early detection of kidney disease

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 141
• Est. completion date: July 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Albuminuria
• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Diagnostic Test:
• Albuminuria test
During participation, subjects are asked to collect one or more urine samples for albuminuria determination.
• HbA1c test
During the screening visit, HbA1c will be measured with a point-of-care test (Affinion HbA1c, Abbott).
• Creatinine test
During the screening visit, creatinine will be measured with a point-of-care test (i-STAT Alinity handheld analyser, Abbott).

Locations

Country	Name	City	State
Netherlands	General Practitioners Research Institute	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
General Practitioners Research Institute	University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of elevated albuminuria	defined as a confirmed urinary albumin creatinine ratio (UACR) = 3.0 mg/mmol.	1-2 weeks after invitation
Secondary	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
Secondary	Average costs per subject	by screening for albuminuria via pharmacies versus general practitioners.	through study completion, an average of 5 weeks
Secondary	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