Method of controlling progression of hyperparathyroidism with calcifediol, and compositions for use therein

A technology for patients and hydroxyvitamins, applied in drug combinations, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve problems such as lack of consensus on definitions

Pending Publication Date: 2021-10-29
EIRGEN PHARMA LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is a lack of consensus on the definition of vitamin D sufficiency in CKD

Method used

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  • Method of controlling progression of hyperparathyroidism with calcifediol, and compositions for use therein
  • Method of controlling progression of hyperparathyroidism with calcifediol, and compositions for use therein
  • Method of controlling progression of hyperparathyroidism with calcifediol, and compositions for use therein

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0100] In two identical, parallel, randomized, double-blind studies, adult subjects (n=429) with SHPT, VDI, and stage 3 or 4 CKD were stratified according to stage and received daily extended-release bone Ethylene glycol (ERC) or placebo treatment. After 26 weeks of treatment, all subjects were sorted by serum total 25-hydroxyvitamin D levels and divided into quintiles to examine the degree of vitamin D supplementation in relation to plasma iPTH, serum bone turnover markers, calcium, phosphorus, and complete composition. Relationship of changes in fibroblast growth factor 23 (FGF23) and vitamin D metabolites, estimated glomerular filtration rate (eGFR), and urinary calcium to creatinine (Ca:Cr) ratio.

[0101] Specifically, two identical 26-week multicenter randomized, double-blind, placebo-controlled design studies recruited a total of SHPT (plasma iPTH ≥85 and 2 ) and VDI (serum total 25-hydroxyvitamin D ≥ 10 and 0.2, nephrotic range proteinuria (>3 mg / mg Cr), and history of...

Embodiment 2

[0131] This example describes a structured chart review of patients with stage 3 or 4 chronic kidney disease with vitamin D insufficiency and secondary hyperparathyroidism who were being treated with extended-release calciferidiol or other relevant comparators. This study addresses mineral and bone disease before dialysis: a real-world assessment of the risks and effectiveness of the current SHPT treatment approach (MBD-AWARE).

[0132] Target

[0133] The overall goal of this study was to generate preliminary real-world evidence that: (a) extended-release calcifediol (ERC) is used in the treatment of adult patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency (VDI) secondary to Safety and Efficacy in Sexual Hyperparathyroidism (SHPT): and (b) Utilization, safety, and efficacy of other vitamin D therapies (OVDT) are considered standard of care for the treatment of SHPT in these patients. OVDTs include nutritional vitamin D (NVD), defined as orall...

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PUM

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Abstract

Methods and compositions for controlling hyperparathyroidism are disclosed.

Description

[0001] Cross References to Related Applications [0002] The benefit of U.S. Provisional Application No. 62 / 802,148, filed February 6, 2019, is hereby claimed pursuant to 35 U.S.C. § 119(e), and is hereby incorporated by reference herein in its entirety. technical field [0003] The present disclosure generally relates to the treatment of patients with elevated serum intact parathyroid hormone, eg, hyperparathyroidism. The present disclosure also relates to treating, eg, SHPT in chronic kidney disease and controlling the progression of SHPT in chronic kidney disease (CKD). Background technique [0004] SHPT is a disease primarily caused by vitamin D insufficiency (VDI) and deficiency. It is characterized by abnormally elevated blood levels of parathyroid hormone (PTH) and, in the absence of early detection and treatment, is associated with hyperplasia and metabolic bone disease clusters of the parathyroid gland. It is a common complication of CKD, and its incidence increas...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/592A61K31/593A61P3/02A61P5/18
CPCA61K31/592A61K31/593A61P3/02A61P5/18
Inventor 查理斯·W·比绍夫
Owner EIRGEN PHARMA LTD
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