MR-proADM Biomarker for CKD Progression Prediction

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Solution Overview

Problem

Current methods fail to effectively predict the progression of chronic kidney disease (CKD) in patients, particularly those at risk of advancing to end-stage renal disease (ESRD), despite advancements in screening and diagnosis.

Innovation Solution

An in vitro method involving the determination of mid-regional pro-adrenomedullin (MR-proADM) levels in patient samples, correlated with the prediction of CKD progression, allowing for the identification of patients likely to progress to ESRD, and potentially used in conjunction with other biomarkers and clinical parameters for enhanced accuracy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If eGFR and K/DOQI classification are used to screen for CKD, then the number of diagnosed CKD patients increases, but the ability to predict progression to ESRD remains insufficient

Engineering Contradiction:
ImproveCKD detection sensitivityVSAvoidprogression prediction accuracy
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The invention transitions from using a single parameter (eGFR) to a multi-parameter approach by introducing MR-proADM and other biomarkers. This parameter expansion enables both sensitive CKD detection and reliable progression prediction, resolving the contradiction between detection sensitivity and progression prediction accuracy.

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If only eGFR is used to assess renal function, then screening is simplified, but risk stratification for CKD progression is inadequate

Engineering Contradiction:
Improvescreening simplicityVSAvoidrisk prediction information
Core Design Contradiction:
Ease of operationVSLoss of information

Solution Approach 1:

The invention segments the assessment into two distinct functions: eGFR continues to handle simple screening and renal function assessment, while MR-proADM and other biomarkers provide specialized progression risk prediction. This segmentation maintains screening simplicity while adding predictive information without complicating the overall workflow.

Inventive Principle:
Principle #1Segmentation

3Reliability

If MR-proADM is added to predict CKD progression, then progression prediction accuracy improves, but the complexity of the assessment increases

Engineering Contradiction:
Improveprogression prediction accuracyVSAvoidassessment complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

MR-proADM serves as an intermediary biomarker that specifically bridges the gap between eGFR-based screening and actual progression outcomes. It translates complex pathophysiological information into a measurable parameter that enhances prediction accuracy without requiring complex assessment protocols, as it can be measured using standard laboratory techniques.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentEP2356466B1Prognostic biomarkers for the progression of primary chronic kidney disease
Publication Date: 2016.12.21 BRAHMS GMBH
  • EP2356466B1 patent drawingFigure 1~5
  • EP2356466B1 patent drawingFigure 6~10
  • EP2356466B1 patent drawingFigure 11

AI summary

Subject of the present invention are assays and in vitro methods for prediction of the progression of primary chronic kidney disease (CKD) or for monitoring chronic kidney disease therapy comprising the determination of the level of ANP and/or ADM or its precursors or fragments thereof.