Chronic Kidney Disease (CKD)NDONCT06447038
Pilot Study for the Early Detection of Chronic Kidney Disease, Non-Dialysis Objective (NDO).
An observational study of Chronic Kidney Disease (CKD), run by Hospital Universitario de Burgos at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease (CKD)
- What is being tested?
- albumin creatinine ratio
- How many people
- 10,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2024to Dec 2024
- How long will I take part?
- 10 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Population of the city of Burgos, Spain who go to their primary doctor.
Who may be able to join
- Minimum age 18 years
Who cannot join
- Age less than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
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.
.
- Conditions
- Chronic Kidney Disease (CKD)
- Being tested
- albumin creatinine ratio
- Keywords
- Epidemiology., Chronic kidney disease., Primary care., Cardiovascular risk factors.
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albumin creatinine ratioDiagnostic test
Albumin creatinine ratio, this test is routinely performed in urine.
| Study group | Role | What they receive |
|---|---|---|
| Population | Population of the city of Burgos > 18 years old. Receives: Diagnostic Test: albumin creatinine ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Albumin creatinine ratio.
Determination of albuminuria in urine.
Measured: 01/02/2024 al 01/12/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 Feb 2024
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease (CKD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Burgos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didier Sánchez OSpina, Hospital Universitario de Burgos
- Investigators
- Maria J Izquierdo Ortiz, Doctor, Study director, HUBUEmilio J Gonzalez Parra, Doctor, Principal investigator, HUBUSebastian Mas Fontao, Doctor, Principal investigator, HUBUMaria Martin Palencia, Doctor, Principal investigator, HUBUDidier Sanchez, Doctor, Study director, HUBU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447038
- Sponsor's protocol ID
- OND 01
- Acronym
- NDO
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Early Detection of Chronic Kidney Disease, Non-Dialysis Objective (NDO).
- ClinicalTrials.gov ID
- NCT06447038
- Acronym / sponsor ID
- NDO / OND 01
- Conditions
- Chronic Kidney Disease (CKD)
- Keywords
- Epidemiology., Chronic kidney disease., Primary care., Cardiovascular risk factors.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Hospital Universitario de BurgosUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 10 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Population | – | Diagnostic Test: albumin creatinine ratioPopulation of the city of Burgos > 18 years old. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Population of the city of Burgos, Spain who go to their primary doctor.
Key inclusion criteria (1 listed)
- Minimum age 18 years
Key exclusion criteria (1 listed)
- Age less than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| albumin creatinine ratioAlbumin creatinine ratio, this test is routinely performed in urine. | Diagnostic test | Population |
Primary outcome
Albumin creatinine ratio.
Time frame: 01/02/2024 al 01/12/2024
Determination of albuminuria in urine.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Background: PubMed 27887750Webster 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria J Izquierdo Ortiz, Doctor study director
HUBU
Emilio J Gonzalez Parra, Doctor principal investigator
HUBU
Sebastian Mas Fontao, Doctor principal investigator
HUBU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease (CKD), run by Hospital Universitario de Burgos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Albumin creatinine ratio. (time frame: 01/02/2024 al 01/12/2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06447038, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.