ClinicalTrials.Veeva

Menu

Towards HOMe-based Albuminuria Screening: an Implementation Study Testing Two Approaches (THOMAS)

U

University Medical Center Groningen (UMCG)

Status

Unknown

Conditions

Albuminuria

Treatments

Diagnostic Test: Approach B (ACR | EU Test kit).
Diagnostic Test: Approach A (PeeSpot urine collection device).

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04295889
LSHM17076-SGF

Details and patient eligibility

About

Chronic Kidney Disease (CKD) is a worldwide major public health problem that is associated with an increased incidence of kidney failure and cardiovascular events, that lead a high burden for affected patients and high costs for society. Symptoms of CKD occur late, when kidney function drops to below 30%. At that time preventive measures will have only limited efficacy. Protein excretion in urine has increasingly been recognized as early marker of CKD, and is often associated with high blood pressure, diabetes, and/or high cholesterol levels. These are all important risk factors for progression of kidney and cardiovascular disease. Population screening for urinary protein loss could detect a considerable number of subjects with yet unknown risk factors for progressive kidney and cardiovascular disease who can benefit of early intervention. However, there is no validated method for population screening yet. The aim is to to develop a home based population screening for elevated urinary protein loss. Two screening methods will be investigated, and yield and cost-effectiveness of these screening methods will be evaluated

Full description

Chronic kidney disease (CKD) is a worldwide major public health problem that is associated with an increased incidence of kidney failure and cardiovascular disease (CVD). To tackle this burden, screening for CKD among the general population could be beneficial to allow early detection and treatment. In the last decades, elevated albuminuria has increasingly been recognized as an early marker of generalized vascular endothelial damage, that predicts CKD and CVD progression.

It has been estimated that approximately 6% of the general population has elevated albuminuria, and that the majority of these subjects are not known yet with this abnormality. Among these subjects, many have hypertension, hyperlipidemia, diabetes and/or impaired kidney function, that often is also not known yet. Early detection of elevated albuminuria may be important because it gives the opportunity to invite subjects that test positive for further screening for CKD and CVD risk factors. Thus these risk factors for CKD and CVD progression could be treated in an early stage.

Population screening for albuminuria could be justified according to the WHO criteria of Wilson and Jungner , because CKD has important consequences for subjects, the course of the disease is initially symptomless, and there are treatment methods available. However, implementation research to validate screening the general population for albuminuria and related health consequences is lacking, as are cost-effectiveness studies.

In the current study the aim is to develop a home-based screening technique for detecting elevated albuminuria. Two screening methods will be investigated, and yield and cost-effectiveness of these screening methods will be evaluated

Enrollment

15,032 estimated patients

Sex

All

Ages

45 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 45 to 80 years.
  • Living in the municipality of Breda, The Netherlands.
  • Not institutionalised.

Exclusion criteria

  • Younger than 45 years or older than 80 years.
  • Not living in the municipality of Breda, The Netherlands.
  • Institutionalised.

A random sample of 15.032 subjects will be drawn from the population aged 45-80 years from the municipality of Breda by the Dutch Central Bureau for Statistics (CBS).

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

15,032 participants in 2 patient groups

Group A
Active Comparator group
Description:
Group A will receive an invitation for home based albuminuria screening using a more conventional urine collection device (known as "Peespot Test").
Treatment:
Diagnostic Test: Approach A (PeeSpot urine collection device).
Group B
Active Comparator group
Description:
Group B will receive an invitation for home based albuminuria screening using an app (internet application) and an ACR dipstick test (known as "ACR\| EU Test").
Treatment:
Diagnostic Test: Approach B (ACR | EU Test kit).

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems