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NCT Number: NCT07751939

Artificial Intelligence Model to Predict Chronic Kidney Outcomes in a Vietnamese Cohort

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.

We 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, we 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Medical Center Ho Chi Minh City (UMC)

Other

Registry information

Official study title

Development of an Artificial Intelligence-Based Prediction Model for Chronic Kidney Disease Outcomes

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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