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Method of treating primary focal segmental glomerulosclerosis

A glomerular sclerosis and focal segmental technique, applied in chemical instruments and methods, pharmaceutical formulations, immunoglobulin, etc.

Inactive Publication Date: 2018-07-17
GENZYME CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] However, in most patients with primary FSGS, treatment with steroids and other therapeutic interventions lead only to transient improvement of proteinuria without altering the disease course

Method used

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  • Method of treating primary focal segmental glomerulosclerosis
  • Method of treating primary focal segmental glomerulosclerosis
  • Method of treating primary focal segmental glomerulosclerosis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0097] A double-blind, parallel-dosing, randomized study of two (2) doses of the test drug formulation or placebo, divided into 3 periods, was conducted in steroid-resistant FSGS patients:

[0098] 1. Screening (1st visit, up to 6 weeks);

[0099] 2. Treatment Periods (Day 1 / Visit 2, Day 28 / Visit 3, Day 56 / Visit 4, Day 84 / Visit 5, and Day 112 / Visit 6 );and

[0100] 3. Follow-up period (Day 140 / Visit 7, Day 168 / Visit 8, and Day 252 / Visit 9).

[0101] On Day 1 / Visit 2, Day 28 / Visit 3, Day 56 / Visit 4, and Day 84 / Visit 5, patients receive a single dose of intravenous (IV) Test drug formulation or placebo infusion. The infusion lasts approximately 30 minutes, and the patient is then left in the clinic for an observation period of at least 30 minutes. Patients are scheduled to return to the clinic on Day 112 / Visit 6 through Day 252 / Visit 9 for follow-up visits.

[0102] Collected at each visit: renal assessment (proteinuria, serum creatinine, and eGFR), serum lipids, serum albu...

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Abstract

A method of treating primary focal segmental glomerulosclerosis in a patient having an APOL1 variant, comprising intravenously administering a TGF[beta] antagonist to the patient.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to US Provisional Application No. 62 / 182,102, filed June 19, 2015. The aforementioned related application is hereby incorporated by reference in its entirety. [0003] US Patent No. 7,723,486, US Patent No. 8,383,780, and US Patent No. 8,591,901 are also hereby incorporated by reference each in its entirety. field of invention [0004] The present invention relates to a method of treating primary focal segmental glomerulosclerosis (primary FSGS) and / or ameliorating one or more symptoms associated with primary FSGS, comprising administering a TGFβ antagonist to patients in need thereof of patients. Specifically, the method involves administering a pharmaceutical formulation comprising a therapeutically effective amount of fresolimumab to a patient with primary FSGS (eg, a patient with a genetic variant that is associated with or an increased risk of developing primary FSGS) so that pati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61P13/12C07K16/22A61K39/395C07K14/775
CPCA61K39/395C07K14/775A61K2039/505C07K16/22A61P13/12A61K9/19A61K2039/54A61K2039/545C07K2317/21C07K2317/76
Inventor S·R·莱德贝特S·恩斯特兰P·芬J·林R·J·蓬波尼奥
Owner GENZYME CORP