Pilot Study for the Early Detection of Chronic Kidney Disease, Non-Dialysis Objective (NDO).

Chronic Kidney Disease (CKD) Clinical Trial

— NDO  

Official title:

Pilot Study for the Early Detection of Chronic Kidney Disease, Non-Dialysis Objective (NDO).

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06447038
• Other study ID #: OND 01
• Status: Enrolling by invitation
• Start date: February 1, 2024
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Hospital Universitario de Burgos
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Chronic kidney disease (CKD) is a significant public health problem worldwide, affecting more than 10% of the Spanish population. Early detection is considered a top healthcare priority to establish strategies for preventing progression to more advanced stages of the disease and its complications. Additionally, CKD is associated with high comorbidity, poor prognosis, and substantial resource consumption within the healthcare system. In this context, albuminuria may be a more sensitive marker of CKD than reduced glomerular filtration rate (GFR), and it is also considered an indicator of not only renal damage but also "systemic damage" (generalized endothelial dysfunction, arterial remodeling, and increased cardiovascular risk) beyond the kidney. Furthermore, the reduction of proteinuria/albuminuria is clearly associated with a slower progression of CKD, making its reduction a therapeutic goal as well. Given this importance, this protocol aims to determine the urine albumin/creatinine ratio in all patients over 18 years old who visit their primary care physician in the province of Burgos, Spain, and require a blood test related to their reason for consultation.

Description:

This is a protocol in which we seek to identify those patients with alterations incipient renal failure by determining the albumin/creatinine ratio in urine, test that is currently performed routinely in different groups of patients. By For this reason, the implementation of the non-dialysis objective protocol hopes to be implemented standardized form in patients who go to their primary attention doctor in the province of Burgos to later be extended to the entire Castilla y Leon community.

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Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Minimum age 18 years

Exclusion Criteria:

• Age less than 18 years

Related Conditions & MeSH terms

• Chronic Kidney Disease (CKD)
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Diagnostic Test:
• albumin creatinine ratio
Albumin creatinine ratio, this test is routinely performed in urine.

Locations

Country	Name	City	State
Spain	Maria J Izquierdo	Burgos

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario de Burgos

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Webster AC, Nagler EV, Morton RL, Masson P. Chronic Kidney Disease. Lancet. 2017 Mar 25;389(10075):1238-1252. doi: 10.1016/S0140-6736(16)32064-5. Epub 2016 Nov 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Albumin creatinine ratio.	Determination of albuminuria in urine.	01/02/2024 al 01/12/2024