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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05321095
Recruitment Status : Recruiting
First Posted : April 11, 2022
Last Update Posted : May 5, 2022
Sponsor:
Collaborator:
General Practitioners Research Institute
Information provided by (Responsible Party):
University Medical Center Groningen

Brief Summary:
Early detection of kidney disease

Condition or disease Intervention/treatment
Chronic Kidney Diseases Albuminuria 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.

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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Screening for Albuminuria at the First Line for Early Identification of Chronic Kidney Disease: a Pilot Study
Actual Study Start Date : November 25, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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 Name: PeeSpot

Diagnostic Test: HbA1c test
During the screening visit, HbA1c will be measured with a point-of-care test (Affinion HbA1c, Abbott).
Other Name: 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 Name: i-STAT Alinity




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


Secondary Outcome Measures :
  1. The prevalence of unknown elevated albuminuria [ Time Frame: through study completion, an average of 5 weeks ]
    defined as elevated albuminuria not reported by the subject or previously recorded in electronic medical records of the subjects' general practice or pharmacy.

  2. Average costs per subject [ Time Frame: through study completion, an average of 5 weeks ]
    by screening for albuminuria via pharmacies versus general practitioners.

  3. the proportion of invited subjects that was identified as having hidden kidney disease [ Time Frame: through study completion, an average of 5 weeks ]
    by screening for albuminuria via pharmacies versus general practitioners.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05321095


Contacts
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Contact: M. Kerkhof, MD PhD 050-2113898 ext 31 saline-studie@gpri.nl
Contact: H.J. Lambers Heerspink, Prof. dr. 050-3617859 ext 31 h.j.lambers.heerspink@umcg.nl

Locations
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Netherlands
General Practitioners Research Institute Recruiting
Groningen, Netherlands, 9713GH
Contact: J.W.H. Kocks, Prof. dr. MD    +31502113898    saline-studie@gpri.nl   
Sponsors and Collaborators
University Medical Center Groningen
General Practitioners Research Institute
Investigators
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Principal Investigator: H.J. Lambers Heerpink, Prof. dr. UMCG
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Responsible Party: University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT05321095    
Other Study ID Numbers: GPRI-21004-CKD
First Posted: April 11, 2022    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Albuminuria
Urologic Diseases
Renal Insufficiency
Proteinuria
Urination Disorders
Urological Manifestations