Clinical trial NCT05321095: Screening for Albuminuria at the First Line for Early Identification of CKD
Official title: Screening for Albuminuria at the First Line for Early Identification of Chronic Kidney Disease: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Albuminuria
Lead sponsor: General Practitioners Research Institute
Sponsor class: NETWORK
Collaborators: name: University Medical Center Groningen
First posted: 2022-04-11
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: The prevalence of elevated albuminuria
timeFrame: 1-2 weeks after invitation
Secondary outcomes:
measure: The prevalence of unknown elevated albuminuria
timeFrame: through study completion, an average of 5 weeks
measure: Average costs per subject
timeFrame: through study completion, an average of 5 weeks
measure: the proportion of invited subjects that was identified as having hidden kidney disease
timeFrame: through study completion, an average of 5 weeks
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: General Practitioners Research Institute
Study officials:
affiliation: UMCG
name: H.J. Lambers Heerpink, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: