Biomarker-Based CIN Risk Prediction in CKD Patients

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Solution Overview

Problem

Current methods for detecting contrast-induced nephropathy (CIN) are delayed and ineffective, particularly in patients with chronic kidney disease (CKD), lacking early detection capabilities and effective preventive strategies.

Innovation Solution

A method involving the determination of L-FABP and NGAL biomarker concentrations in serum samples, combined with statistical analysis, to predict the risk of CIN and inform timely interventions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If creatinine is used as a biomarker for detecting AKI, then the detection is simple and widely available, but the detection is delayed and poor at early detection of acute tubular necrosis

Engineering Contradiction:
Improveearly detection capabilityVSAvoiddetection delay
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent measures biomarker levels (NGAL, L-FABP, KIM-1, IL-18) before contrast media administration to establish baseline levels, enabling early detection of AKI risk before the condition fully develops. This preliminary measurement approach allows for proactive identification of patients at risk, addressing the detection delay inherent in using creatinine alone.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent introduces multiple intermediate biomarkers (NGAL, L-FABP, KIM-1, IL-18) that serve as mediators between the initial renal injury and the final creatinine elevation. These biomarkers appear in the blood stream earlier than creatinine, providing an intermediate detection signal that bridges the gap between early injury and late creatinine-based diagnosis.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If multiple biomarkers are measured to improve early detection accuracy, then the prediction accuracy improves, but the complexity of the diagnostic process increases

Engineering Contradiction:
ImproveCIN risk prediction accuracyVSAvoiddiagnostic process complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent combines multiple biomarker measurements (NGAL, L-FABP, KIM-1, IL-18) into a single integrated diagnostic approach. By measuring all these markers together and analyzing their combined patterns, the patent achieves high prediction accuracy while managing complexity through a unified testing protocol rather than separate sequential tests.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent monitors changes in biomarker levels from baseline (pre-contrast) to post-contrast time points. By focusing on the dynamic changes rather than absolute values, and by using statistical analysis to interpret these changes, the patent simplifies the interpretation process while maintaining high predictive accuracy for CIN risk.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If preventive strategies are implemented early to reduce CIN risk, then the morbidity and hospital stay are reduced, but the cost and resource utilization increase

Engineering Contradiction:
Improvepatient outcome reliabilityVSAvoidresource utilization
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The patent applies preventive strategies selectively to patients identified as high-risk through biomarker analysis, rather than universally to all patients. By concentrating resources on the specific subgroup of patients who show elevated biomarker levels indicating CIN risk, the patent improves patient outcomes for those who need intervention most while avoiding unnecessary resource utilization in low-risk patients.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent uses biomarker measurements to provide feedback on individual patient risk status, which then guides the application of preventive strategies. This feedback mechanism ensures that preventive resources are allocated based on actual patient need as indicated by objective biomarker data, optimizing the balance between outcome improvement and resource utilization.

Inventive Principle:
Principle #23Feedback

Data Source

PatentEP3368906B1Method for predicting contrast induced nephropathy
Publication Date: 2025.12.31 RANDOX LAB LTD
  • EP3368906B1 patent drawingFigure 1
  • EP3368906B1 patent drawingFigure 2a~2e
  • EP3368906B1 patent drawingFigure 3

AI summary

The use of biomarkers for establishing risk of developing contrast-induced nephropathy (CIN) in patients with pre-existent chronic kidney disease (CKD) is described.