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临床试验/NCT07751939
NCT07751939进行中(未招募)不适用

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

University Medical Center Ho Chi Minh City (UMC)1 个研究点 分布在 1 个国家目标入组 1,182 人开始时间: 2025年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
1,182
试验地点
1
主要终点
Composite of CKD progression and renal or cardiovascular death

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Composite of CKD progression and renal or cardiovascular death

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
University Medical Center Ho Chi Minh City (UMC)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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