Chronic Kidney DiseaseNCT07751939
Artificial Intelligence Model to Predict Chronic Kidney Outcomes in a Vietnamese Cohort
An observational study of Chronic Kidney Disease, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
Trial summary
Chronic kidney disease (CKD) is a common condition that imposes a substantial health burden and contributes significantly to global morbidity and mortality. In the United States, 2024 data indicate that about 14% of adults - more than 31 million people - have CKD, costing hundreds of billions of dollars each year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 1,182 participants
- Where
- 1 siteVietnam
- Study dates
- 2 Oct 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with chronic kidney disease managed at the University Medical Center Ho Chi Minh City.
Who may be able to join
- Age >= 18 years.
- eGFR 20-60 mL/min/1.73 m2, stable for at least 3 months before enrolment.
- Provides written informed consent to participate.
Who cannot join
- Currently receiving kidney replacement therapy (haemodialysis, peritoneal dialysis, or kidney transplant).
- Acute illness at enrolment (acute infection, acute heart failure, or progressive liver disease).
- Current malignancy.
- Life expectancy < 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of an Artificial Intelligence-Based Prediction Model for Chronic Kidney Disease Outcomes
Chronic kidney disease (CKD) is a common condition that imposes a substantial health burden and contributes significantly to global morbidity and mortality. In the United States, 2024 data indicate that about 14% of adults - more than 31 million people - have CKD, costing hundreds of billions of dollars each year. In Vietnam, the estimated prevalence is 12.8%, affecting roughly 10 million people. Because CKD often progresses silently, reliable early prediction of adverse outcomes - end-stage kidney disease (ESKD), disease progression, and death - carries considerable clinical value. Timely intervention in high-risk patients can improve quality of life and reduce morbidity, mortality, and the costs arising from kidney replacement therapy. Several statistical models predict CKD outcomes from variables such as age, sex, eGFR, and albuminuria. However, most were developed predominantly in White populations, and evidence for their generalizability to other ethnic groups, including Vietnamese, remains scarce. Some models omit proteinuria despite its strong prognostic role in CKD, and most do not account for therapies proven to slow progression, such as renin-angiotensin-aldosterone system (RAAS) inhibitors and sodium-glucose cotransporter-2 (SGLT2) inhibitors.
Machine learning (ML), a branch of artificial intelligence, enables computers to learn latent patterns from data and make predictions without being explicitly programmed. Compared with traditional statistics, ML can represent complex, non-linear, and highly collinear relationships that conventional regression may miss, and has recently shown superior predictive performance across many clinical settings.
Read more
Contemporary CKD care has advanced substantially: landmark trials have established the renal and cardiovascular benefits of SGLT2 inhibitors regardless of diabetes status, and current KDIGO guidance emphasizes risk-based, individualized management. Prediction models built before this therapeutic era may no longer capture current risk adequately.
The investigators therefore propose to develop an artificial intelligence-based model to predict CKD outcomes suited to the new treatment era in the Vietnamese population. Outcomes comprise disease progression (a ≥ 40% decline in eGFR or ESKD) and renal or cardiovascular death. Predictors are restricted to baseline comorbidities and routine blood and urine tests that are widely recommended for CKD monitoring.
Using a prospective cohort, the investigators will determine the 2-year incidence of these composite events, develop and compare several ML algorithms (logistic regression, random forest, decision tree, Naïve Bayes, k-nearest neighbours, and support vector machine...), benchmark them against existing equations (KFRE and CKD-PC), and select the optimal model, using SHAP-based interpretation to clarify each predictor's contribution. The minimum sample size of 1,182 was derived using the method of Riley.
- Conditions
- Chronic Kidney Disease
- Keywords
- Machine Learning, Artificial Intelligence, Prediction Model, eGFR, Vietnamese cohort
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of CKD progression and renal or cardiovascular death
Incidence of the composite outcome, defined as disease progression (a >= 40% decline in eGFR or end-stage kidney disease [ESKD]) or renal or cardiovascular death.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start2 Oct 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751939
- Sponsor's protocol ID
- IRB-VN01002/IRB00010293
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Artificial Intelligence-Based Prediction Model for Chronic Kidney Disease Outcomes
- ClinicalTrials.gov ID
- NCT07751939
- Acronym / sponsor ID
- IRB-VN01002/IRB00010293
- Conditions
- Chronic Kidney Disease
- Keywords
- Machine Learning, Artificial Intelligence, Prediction Model, eGFR, Vietnamese cohort
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,182 participants (estimated)
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)University, hospital or other
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Aug 2026 (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 common condition that imposes a substantial health burden and contributes significantly to global morbidity and mortality. In the United States, 2024 data indicate that about 14% of adults - more than 31 million people - have CKD, costing hundreds of billions of dollars each year. In Vietnam, the estimated prevalence is 12.8%, affecting roughly 10 million people. Because CKD often progresses silently, reliable early prediction of adverse outcomes - end-stage kidney disease (ESKD), disease progression, and death - carries considerable clinical value. Timely intervention in high-risk patients can improve quality of life and reduce morbidity, mortality, and the costs arising from kidney replacement therapy. Several statistical models predict CKD outcomes from variables such as age, sex, eGFR, and albuminuria. However, most were developed predominantly in White populations, and evidence for their generalizability to other ethnic groups, including Vietnamese, remains scarce. Some models omit proteinuria despite its strong prognostic role in CKD, and most do not account for therapies proven to slow progression, such as renin-angiotensin-aldosterone system (RAAS) inhibitors and sodium-glucose cotransporter-2 (SGLT2) inhibitors.
Machine learning (ML), a branch of artificial intelligence, enables computers to learn latent patterns from data and make predictions without being explicitly programmed. Compared with traditional statistics, ML can represent complex, non-linear, and highly collinear relationships that conventional regression may miss, and has recently shown superior predictive performance across many clinical settings.
Contemporary CKD care has advanced substantially: landmark trials have established the renal and cardiovascular benefits of SGLT2 inhibitors regardless of diabetes status, and current KDIGO guidance emphasizes risk-based, individualized management. Prediction models built before this therapeutic era may no longer capture current risk adequately.
The investigators therefore propose to develop an artificial intelligence-based model to predict CKD outcomes suited to the new treatment era in the Vietnamese population. Outcomes comprise disease progression (a ≥ 40% decline in eGFR or ESKD) and renal or cardiovascular death. Predictors are restricted to baseline comorbidities and routine blood and urine tests that are widely recommended for CKD monitoring.
Using a prospective cohort, the investigators will determine the 2-year incidence of these composite events, develop and compare several ML algorithms (logistic regression, random forest, decision tree, Naïve Bayes, k-nearest neighbours, and support vector machine...), benchmark them against existing equations (KFRE and CKD-PC), and select the optimal model, using SHAP-based interpretation to clarify each predictor's contribution. The minimum sample size of 1,182 was derived using the method of Riley.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with chronic kidney disease managed at the University Medical Center Ho Chi Minh City.
Key inclusion criteria (3 listed)
- Age >= 18 years.
- eGFR 20-60 mL/min/1.73 m2, stable for at least 3 months before enrolment.
- Provides written informed consent to participate.
Key exclusion criteria (4 listed)
- Currently receiving kidney replacement therapy (haemodialysis, peritoneal dialysis, or kidney transplant).
- Acute illness at enrolment (acute infection, acute heart failure, or progressive liver disease).
- Current malignancy.
- Life expectancy < 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite of CKD progression and renal or cardiovascular death
Time frame: 2 years
Incidence of the composite outcome, defined as disease progression (a >= 40% decline in eGFR or end-stage kidney disease [ESKD]) or renal or cardiovascular death.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. 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 Vietnam. 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?
This study is still under way. Results are not available in the source record yet.
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?
Composite of CKD progression and renal or cardiovascular death (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2026.