Urinary peptide-based classifier CKD273: towards clinical application in chronic kidney disease

Area of Science:

• Biomarker discovery and validation
• Proteomics and metabolomics
• Clinical diagnostics

Background:

• Chronic kidney disease (CKD) affects 10% of the population, incurring significant healthcare costs.
• Urinary proteome analysis offers a non-invasive approach for CKD assessment.
• Early detection and intervention are crucial for managing CKD progression.

Purpose of the Study:

• To review the evidence supporting the CKD273 urinary proteome-based classifier.
• To discuss the implementation challenges and future directions for CKD biomarkers.
• To highlight the role of CKD273 in early CKD detection and patient stratification.

Main Methods:

• Capillary electrophoresis coupled with mass spectrometry (CE-MS) for peptide discovery and validation.
• Cross-sectional and longitudinal studies involving large patient cohorts (>1000 patients).
• Evaluation of classifier validity using established evidence-based medicine guidelines.

Main Results:

• The CKD273 classifier has been discovered and validated for assessing and predicting CKD progression.
• CKD273 is commercially available as an in vitro diagnostic test for early CKD detection.
• The classifier is utilized for patient stratification in a multicentre randomized clinical trial (PRIORITY).

Conclusions:

• The CKD273 classifier demonstrates validity and has received support from the US Food and Drug Administration.
• Combining CKD273 with a surrogate early endpoint is a promising strategy for drug development in early CKD.
• Effective implementation of CKD biomarkers like CKD273 is key to developing timely and effective CKD interventions.