NCT06447038

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

June 6, 2024

Status Verified

June 1, 2024

Enrollment Period

8 months

First QC Date

June 3, 2024

Last Update Submit

June 3, 2024

Conditions

Keywords

Epidemiology.Chronic kidney disease.Primary care.Cardiovascular risk factors.

Outcome Measures

Primary Outcomes (1)

  • Albumin creatinine ratio.

    Determination of albuminuria in urine.

    01/02/2024 al 01/12/2024

Study Arms (1)

Population

Population of the city of Burgos \> 18 years old.

Diagnostic Test: albumin creatinine ratio

Interventions

Albumin creatinine ratio, this test is routinely performed in urine.

Population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Population of the city of Burgos, Spain who go to their primary doctor.

You may qualify if:

  • Minimum age 18 years

You may not qualify if:

  • Age less than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maria J Izquierdo

Burgos, 09003, Spain

Location

Related 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.

    PMID: 27887750BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maria J Izquierdo Ortiz, Doctor

    HUBU

    STUDY DIRECTOR
  • Emilio J Gonzalez Parra, Doctor

    HUBU

    PRINCIPAL INVESTIGATOR
  • Sebastian Mas Fontao, Doctor

    HUBU

    PRINCIPAL INVESTIGATOR
  • Maria Martin Palencia, Doctor

    HUBU

    PRINCIPAL INVESTIGATOR
  • Didier Sanchez, Doctor

    HUBU

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Target Duration
10 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor investigator

Study Record Dates

First Submitted

June 3, 2024

First Posted

June 6, 2024

Study Start

February 1, 2024

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

June 6, 2024

Record last verified: 2024-06

Locations