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Background <p>Chronic kidney disease (CKD) is a major global health burden. Serum creatinine, the current standard biomarker, has well-recognized limitations related to age, sex, and muscle mass. Beta-trace protein (BTP), a low-molecular-weight glycoprotein filtered freely at the glomerulus, has emerged as a promising supplementary marker of glomerular filtration rate (GFR).</p> Objective <p>To evaluate the diagnostic performance of serum BTP and its association with established renal function parameters in CKD patients compared with healthy controls.</p> Methods <p>A case-control study was conducted at Government Medical College, Rajouri, India (February 2020–December 2021). One hundred CKD patients with confirmed GFR 15–59 mL/min/1.73&#xa0;m² (KDIGO stages G3a–G4) and 100 healthy hospital staff controls were enrolled. Serum BTP was measured by ELISA. Statistical analyses included independent-samples t-tests, Pearson correlation, ROC curve analysis, and multivariable logistic regression adjusting for age, sex, BMI, and fasting blood glucose (FBG).</p> Results <p>CKD patients had significantly higher BTP (63.47 ± 27.05 vs. 32.97 ± 10.92 ng/mL; <i>p</i> &lt; 0.001; Cohen’s d = 1.48). ROC analysis yielded AUC 0.87 (95% CI: 0.82–0.92; <i>p</i> &lt; 0.001) with an optimal cutoff of 44.2 ng/mL (sensitivity 81%, specificity 85%). BTP was negatively correlated with CCR (<i>r</i> = − 0.71; <i>p</i> &lt; 0.001) and positively correlated with serum creatinine (r = + 0.68; <i>p</i> &lt; 0.001). On multivariate regression, BTP remained an independent predictor of CKD status (adjusted OR 1.08 per ng/mL; 95% CI: 1.05–1.11; <i>p</i> &lt; 0.001). BTP levels were significantly higher in KDIGO G4 than G3a–G3b patients (78.3 ± 24.1 vs. 52.6 ± 21.8 ng/mL; <i>p</i> &lt; 0.001).</p> Conclusion <p>Serum BTP is significantly elevated in CKD patients and demonstrates independent diagnostic utility (AUC 0.87) alongside established renal function markers. These findings support BTP as a complementary biomarker, though prospective studies in larger and more diverse populations are needed before clinical integration.</p>

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Evaluation of beta-trace protein as a potential biomarker of renal dysfunction in chronic kidney disease: a case-control study

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  • 发表日期：

    2026年7月29日

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  • Mohit Thalquotra,
  • Joginder Singh,
  • Abhishek Bansal,
  • Rajinderjit Singh Ahi,
  • Anil Kumar,
  • Zahid Gillani

摘要

Background

Chronic kidney disease (CKD) is a major global health burden. Serum creatinine, the current standard biomarker, has well-recognized limitations related to age, sex, and muscle mass. Beta-trace protein (BTP), a low-molecular-weight glycoprotein filtered freely at the glomerulus, has emerged as a promising supplementary marker of glomerular filtration rate (GFR).

Objective

To evaluate the diagnostic performance of serum BTP and its association with established renal function parameters in CKD patients compared with healthy controls.

Methods

A case-control study was conducted at Government Medical College, Rajouri, India (February 2020–December 2021). One hundred CKD patients with confirmed GFR 15–59 mL/min/1.73 m² (KDIGO stages G3a–G4) and 100 healthy hospital staff controls were enrolled. Serum BTP was measured by ELISA. Statistical analyses included independent-samples t-tests, Pearson correlation, ROC curve analysis, and multivariable logistic regression adjusting for age, sex, BMI, and fasting blood glucose (FBG).

Results

CKD patients had significantly higher BTP (63.47 ± 27.05 vs. 32.97 ± 10.92 ng/mL; p < 0.001; Cohen’s d = 1.48). ROC analysis yielded AUC 0.87 (95% CI: 0.82–0.92; p < 0.001) with an optimal cutoff of 44.2 ng/mL (sensitivity 81%, specificity 85%). BTP was negatively correlated with CCR (r = − 0.71; p < 0.001) and positively correlated with serum creatinine (r = + 0.68; p < 0.001). On multivariate regression, BTP remained an independent predictor of CKD status (adjusted OR 1.08 per ng/mL; 95% CI: 1.05–1.11; p < 0.001). BTP levels were significantly higher in KDIGO G4 than G3a–G3b patients (78.3 ± 24.1 vs. 52.6 ± 21.8 ng/mL; p < 0.001).

Conclusion

Serum BTP is significantly elevated in CKD patients and demonstrates independent diagnostic utility (AUC 0.87) alongside established renal function markers. These findings support BTP as a complementary biomarker, though prospective studies in larger and more diverse populations are needed before clinical integration.