CClinicalTrials.gg
Enrolling by invitationNCT06447038NDOUpdated Jun 6, 2024

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

An observational study in Chronic Kidney Disease (CKD), sponsored by Hospital Universitario de Burgos. Enrolling by invitation at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-06.

Sponsored by Hospital Universitario de Burgos · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
10,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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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02

Conditions studied

  • Chronic Kidney Disease (CKD)

Keywords

  • Epidemiology.
  • Chronic kidney disease.
  • Primary care.
  • Cardiovascular risk factors.
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Hospital Universitario de Burgos is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Inclusion criteria

  • Minimum age 18 years

Exclusion criteria

Exclusion Criteria:

  • Age less than 18 years
05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Target follow-up
10 Months
Patient registry
Yes

Groups and cohorts

  • Population

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

    Diagnostic Test: albumin creatinine ratio

Interventions

  • Diagnostic testalbumin creatinine ratio

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

06

What researchers measure

Primary outcomes

  1. Albumin creatinine ratio.

    Determination of albuminuria in urine.

    Time frame: 01/02/2024 al 01/12/2024

07

Study locations

1 site
  • Maria J Izquierdo
    Burgos, 09003, Spain
08

References and documents

Publications

  • 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. PubMed 27887750 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06447038
Lead sponsor
Hospital Universitario de Burgos
Responsible party
Didier Sánchez OSpina (Doctor investigator, Hospital Universitario de Burgos) — Principal investigator
First posted
Jun 6, 2024
Start date
Feb 1, 2024
Primary completion
Oct 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Jun 6, 2024

Study contacts

Maria J Izquierdo Ortiz, Doctor
study director · HUBU
Emilio J Gonzalez Parra, Doctor
principal investigator · HUBU
Sebastian Mas Fontao, Doctor
principal investigator · HUBU
Maria Martin Palencia, Doctor
principal investigator · HUBU
Didier Sanchez, Doctor
study director · HUBU

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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