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
|Condition or disease||Intervention/treatment|
|Chronic Kidney Diseases Albuminuria||Diagnostic Test: Albuminuria test Diagnostic Test: HbA1c test Diagnostic Test: Creatinine test|
|Study Type :||Observational|
|Estimated Enrollment :||110 participants|
|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|
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
- 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.
- 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.
- Average costs per subject [ Time Frame: through study completion, an average of 5 weeks ]by screening for albuminuria via pharmacies versus general practitioners.
- 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.
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
|Contact: M. Kerkhof, MD PhD||050-2113898 ext email@example.com|
|Contact: H.J. Lambers Heerspink, Prof. dr.||050-3617859 ext firstname.lastname@example.org|
|General Practitioners Research Institute||Recruiting|
|Groningen, Netherlands, 9713GH|
|Contact: J.W.H. Kocks, Prof. dr. MD +31502113898 email@example.com|
|Principal Investigator:||H.J. Lambers Heerpink, Prof. dr.||UMCG|