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Methods for increasing mean corpuscular volume

An individual, compound technology for the treatment of hemoglobin deficiency

Inactive Publication Date: 2013-12-04
FIBROGEN INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Low MCV means insufficient iron to make RBCs and is often caused by ESAs treatment

Method used

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  • Methods for increasing mean corpuscular volume
  • Methods for increasing mean corpuscular volume
  • Methods for increasing mean corpuscular volume

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Example 1: Increasing mean corpuscular volume (MCV) in human subjects with end-stage renal disease

[0055] The effect of compounds of the invention on MCV was determined in human subjects with end-stage renal disease as follows. Subjects had been on stable maintenance hemodialysis for at least four months prior to the start of the study. Also prior to the start of the study presented here, the subject had been receiving a stable standard of care dose of epoetin alfa for the treatment of anemia.

[0056] To examine the difference in MCV response in individuals treated with compounds of the present invention versus those treated with epoetin alfa (the current standard of care), all intravenous iron supplementation was stopped two weeks prior to treatment. Oral iron supplementation is permitted.

[0057] Subjects were administered Compound A (1.0 mg / kg, 1.5 mg / kg, or 2.0 mg / kg) or epoetin alfa three times per week (TIW) for six weeks. Baseline MCV levels (mean values ​...

Embodiment 2

[0066] Example 2: Increasing mean corpuscular volume (MCV) in human subjects with chronic kidney disease

[0067] In another series of experiments, the effect of the compounds of the invention on MCV was determined in stage III and IV chronic kidney disease patients (estimated glomerular filtration rate eGFR<59 ml / min) as follows. Individuals with stage III and stage IV chronic kidney disease were administered placebo or Compound A (1.5 mg / kg or 2.0 mg / kg) two or three times per week for 4 weeks. MCV values ​​were determined weekly.

[0068] Such as image 3 As shown, mean MCV increased over time in subjects administered Compound A at doses of 1.5 mg / kg or 2.0 mg / kg. In placebo-treated control individuals, there was no increase in mean MCV. Figure 4 The mean change from baseline MCV observed in treated and control individuals is shown. Such as Figure 4 As shown, the mean change (ie, increase) from baseline MCV in subjects administered Compound A was greater than 3 fL at 2...

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PUM

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Abstract

The invention relates to methods and compounds useful for treating deficiencies in hemoglobin production. Methods and compounds useful for increasing mean corpuscular volume are provided. Methods and compounds for treating microcytosis and methods and compounds for treating microcytic anemia are also provided.

Description

technical field [0001] The present invention relates to methods and compounds useful in the treatment of insufficient hemoglobin production. Methods and compounds for increasing mean corpuscular volume are provided. Methods and compounds for treating microcytosis, and methods and compounds for treating microcytic anemia are provided. Background technique [0002] Effective treatment of anemia in a human subject requires a coordinated response that overcomes the pathophysiological stress that antagonizes red blood cell (RBC) production, resulting in the generation of sufficient numbers of normal RBCs that can be maintained over time. Anemia usually stems from any attack on the function of the kidneys or bone marrow, since these organs are the essential signaling and site of production of new RBCs, respectively. Thus, patients with renal dysfunction, such as chronic kidney disease, often suffer from anemia, the severity of which increases with the degree of the disorder. In...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/472A61P7/06
CPCC07D217/24A61K31/472A61P7/06
Inventor 金亨·余
Owner FIBROGEN INC