1,25-dihydroxyvitamin D to PTH Ratio for Renal Function Prediction

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Solution Overview

Problem

Current methods lack reliable and efficient means to predict or stratify the risk of worsening renal function in patients with renal injury, particularly due to the challenges in measuring and interpreting levels of 1,25-dihydroxyvitamin D, a key biomarker.

Innovation Solution

A method involving the measurement of 1,25(OH)2D and parathyroid hormone (PTH) levels in patients, calculating their ratio, and using this ratio to predict or stratify the risk of worsening renal function, with a predetermined threshold determining the likelihood of renal function deterioration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If serum creatinine is used as a marker of renal injury, then it is widely available and easy to measure, but it is slowly affected by changes in renal function and dependent on multiple factors such as muscle mass, sex, race and age

Engineering Contradiction:
Improveease of measurementVSAvoidprecision of renal function assessment
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent introduces 1,25-dihydroxyvitamin D and PTH as intermediary biomarkers that mediate the assessment of renal function. These markers serve as intermediaries between direct renal function measurement and clinical assessment, providing a more sensitive indicator of renal injury that is not confounded by muscle mass, sex, race or age factors affecting creatinine

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent changes the measurement parameter from serum creatinine to the ratio of 1,25-dihydroxyvitamin D to PTH. This parameter change enables more precise detection of renal function deterioration by measuring substances whose levels are directly affected by renal injury rather than by demographic or physiological variables

Inventive Principle:
Principle #35Parameter changes

2Reliability

If 1,25-dihydroxyvitamin D levels are measured alone, then it provides information about vitamin D status, but it does not adequately predict worsening renal function without context

Engineering Contradiction:
Improvepredictive value for renal functionVSAvoidcontextual information about mineral metabolism
Core Design Contradiction:
ReliabilityVSLoss of information

Solution Approach 1:

The patent merges the measurement of 1,25-dihydroxyvitamin D with PTH levels into a unified prognostic indicator. By combining these two biomarkers into a ratio, the invention creates a more reliable predictor of worsening renal function that integrates information about both vitamin D metabolism and parathyroid hormone regulation, neither of which is sufficiently predictive alone

Inventive Principle:
Principle #5Merging (Combining)

3Reliability

If traditional renal function markers are used, then they are well-established in clinical practice, but they lack the sensitivity to early predict and identify patients at risk for future worsening renal function

Engineering Contradiction:
Improveearly prediction capabilityVSAvoidtime for intervention
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent enables preliminary identification of patients at risk for worsening renal function by measuring the 1,25-dihydroxyvitamin D to PTH ratio before clinical deterioration occurs. This preliminary action allows clinicians to identify at-risk patients early and intervene before significant renal function loss occurs, gaining valuable time for preventive treatment

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS10983136B2Use of 1,25-dihydroxyvitamin D values in ratio with PTH as a prognostic biomarker
Publication Date: 2021.04.20 DIASORIN ITALIA SPA
  • US10983136B2 patent drawing
  • US10983136B2 patent drawing
  • US10983136B2 patent drawing

AI summary

The present invention relates to the use of 1,25-dihydroxyvitamin D values in ratio with PTH as a prognostic biomarker. More particularly, the present invention relates to a method for predicting or stratifying the risk of worsening renal function (WRF) in a patient at risk of renal injury or affected by renal injury. Levels of 1,25-dihydroxyvitamin D (1,25(OH)2D) are measured in a biological sample and taken together with parathyroid hormone (PTH) levels to provide a ratio indicative of the risk of worsening renal function.