Ferric Citrate Phosphate Binder for CKD Anemia

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Solution Overview

Problem

Current treatments for chronic kidney disease (CKD) patients, particularly those with iron deficiency and anemia, face challenges due to poor bioavailability of oral iron supplements and risks associated with intravenous iron, leading to inadequate iron stores and increased medical costs.

Innovation Solution

Ferric citrate is used as a clinically safe and effective phosphate binder to reduce serum phosphorus levels, increase iron storage parameters, and improve hemoglobin concentrations, thereby reducing the need for intravenous iron and erythropoiesis-stimulating agents, administered orally in a controlled dosage form.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If oral iron supplements are administered to CKD patients, then iron stores can be replenished, but bioavailability is poor and treatment effectiveness is limited

Engineering Contradiction:
Improveiron storesVSAvoidbioavailability
Core Design Contradiction:
Quantity of substanceVSReliability

Solution Approach 1:

The patent changes the chemical form of iron from traditional ferrous sulfate to ferric citrate, altering the chemical parameters to improve solubility and absorption. The ferric citrate formulation provides better bioavailability while maintaining oral administration, directly addressing the contradiction between replenishing iron stores and achieving reliable absorption

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention uses a composite approach by combining ferric citrate with specific dosing regimens and formulations that enhance absorption. The composite material strategy involves optimizing the chemical composition and physical form of the iron supplement to overcome the bioavailability limitations of traditional oral iron therapies

Inventive Principle:
Principle #40Composite materials

2Quantity of substance

If intravenous iron is administered to CKD patients, then iron stores can be effectively replenished, but safety risks increase

Engineering Contradiction:
Improveiron storesVSAvoidsafety risks
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The patent introduces ferric citrate as an intermediary substance that bridges the gap between oral and intravenous iron administration. This intermediary approach allows achieving the effectiveness of IV iron (significant iron store replenishment) while maintaining the safety profile of oral administration, avoiding the harmful effects associated with IV iron

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention adopts a disposable oral formulation that eliminates the need for repeated invasive IV procedures. By using a safe oral alternative that effectively replenishes iron stores, the treatment avoids the cumulative safety risks of multiple IV iron administrations while maintaining treatment effectiveness

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Reliability

If traditional iron supplements are used in CKD patients, then anemia treatment is attempted, but treatment costs increase due to inadequate effectiveness

Engineering Contradiction:
Improveanemia treatment effectivenessVSAvoidmedical costs
Core Design Contradiction:
ReliabilityVSLoss of energy

Solution Approach 1:

The patent changes the therapeutic parameters by using ferric citrate with optimized dosing (e.g., 210-630 mg elemental iron daily) that achieves better anemia treatment effectiveness. This parameter optimization reduces the need for additional interventions and decreases overall medical costs associated with inadequate anemia management in CKD patients

Inventive Principle:
Principle #35Parameter changes

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Ferric citrate effectively maintains iron stores, treats anemia, and decreases the reliance on IV iron and ESAs, offering a safer and more effective long-term treatment option for CKD patients, including those with end-stage renal disease.

Implementation Method 1

ferric citrate is used as a clinically safe and effective phosphate binder to reduce serum phosphorus levels

Methodology Applied
Scientific EffectChelation:

Implementation Method 2

ferric citrate... to reduce serum phosphorus levels

Methodology Applied
Scientific EffectPrecipitation: Precipitation

Implementation Method 3

The ferric iron is reduced to ferrous iron, which is then absorbed

Methodology Applied
Scientific EffectReduction: Reduction

Data Source

PatentEP3730136B1Use of ferric citrate in the treatment of chronic kidney disease patients
Publication Date: 2023.12.27 KERYX BIOPHARMACEUTICALS INC

AI summary

Methods of administering ferric citrate to reduce and/or control serum phosphorus levels, increase serum bicarbonate levels, improve one or more iron storage parameters (e.g., increase serum ferritin levels, increase transferrin saturation (TSAT), increase hemoglobin concentration) increase iron absorption, maintain iron stores, treat iron deficiency, treat anemia, reduce the need for IV iron and/or reduce the need for erythropoiesis-stimulating agents (ESAs) in chronic kidney disease patients, are disclosed.