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

Summary

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

Conditions

• Albuminuria

Interventions

DIAGNOSTIC_TEST

Approach A (PeeSpot urine collection device).

The participant will receive the PeeSpot urine collection device (Hessels+Grob B.V., Deventer, The Netherlands), which consists of a holder containing a urine collection pad (consisting of hygroscopic material containing). The holder can be placed back into the tube and can be easily sent to the laboratory by mail. In this urine, albumin, creatinine, and the ACR will be measured in the laboratory of the Amphia hospital.

DIAGNOSTIC_TEST

Approach B (ACR | EU Test kit).

The participant will receive the ACR \| EU test kit (Healthy.io Ltd, Tel-Aviv- Yafo, Israel), which consists of a urine test strip, a urine cup, a color calibrator and instruction to download a smartphone application. The participants have to download the smartphone application according to the instructions included in the kit. Results will be directly shown to the participant in the app.

Sponsors & Collaborators

• Dutch Kidney Foundation

  collaborator OTHER

• E-Zorg B.V. / KPN Health

  collaborator UNKNOWN

• Healthy.io Ltd.

  collaborator INDUSTRY

• Hessels+Grob

  collaborator UNKNOWN

• Copernicus Interchange Technology B.V.

  collaborator UNKNOWN

• Amphia Hospital

  collaborator OTHER

• University Medical Center Groningen

  lead OTHER

Principal Investigators

• Ron T Gansevoort, MD, PhD · University Medical Center Groningen

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-14

Primary Completion

2022-04-01

Completion

2022-07-01

Countries

• Netherlands

Study Locations