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Pyridoxamine for the treatment of diabetic kidney disease

a technology of pyridoxamine and kidney disease, which is applied in the direction of biocide, drug composition, metabolic disorder, etc., can solve the problems of poor renal function, poor renal function, and inability to effectively filter blood in the glomerulus of patients, so as to and limit the progression of renal disease and/or diabetic complications

Inactive Publication Date: 2005-01-20
NEPHROGENEX
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0006] In a further aspect, the present invention provides methods for limiting the progression of renal disease and / or diabetic complications in a human diabetic patient, comprising administering to the human diabetic patient an amount of pyridoxamine, or a pharmaceutically acceptable salt thereof, effective to limit the progression of renal disease and / or diabetic complications in the diabetic human patient.

Problems solved by technology

As renal damage progresses, patients lose the ability to effectively filter the blood in the glomerulus and can progress to the need for dialysis or transplantation.
Diabetic nephropathy, and in particular dialysis and transplantation, is costly both in terms of medical treatment and in lost productivity.

Method used

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  • Pyridoxamine for the treatment of diabetic kidney disease
  • Pyridoxamine for the treatment of diabetic kidney disease
  • Pyridoxamine for the treatment of diabetic kidney disease

Examples

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Effect test

example

[0051] A randomized, double-blind, placebo-controlled, multicenter trial which examined the safety profile of pyridoxamine dihydrochloride (PYR) in patients with type 1 and type 2 diabetes mellitus (“DM”) and overt nephropathy was conducted (“206 study”). 128 patients (48 type 1, 80 type 2) at 32 sites were randomized to receive either PYR 50 mg twice a day (b.i.d) or placebo for six months. 58 patients in each group completed the study. Groups were well matched at baseline for age, race, gender, blood pressure, hemoglobin A1C (HbA1C), and angiotensin converting enzyme inhibitor (ACEI) / angiotensin receptor blocker (ARB) use.

[0052] Baseline characteristics of the patients included serum creatinine=1.27 mg / dL and urinary albumin excretion=868 mg / 12 h in treatment, versus 1.33 mg / dL and 1055 mg / 12 h in placebo groups (differences not significant, NS).

[0053] No significant differences in treatment-related adverse events (26% PYR, 33% placebo), study discontinuation due to AE's (6% PYR...

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Abstract

The present invention provides pharmaceutical compositions comprising dosage units of pyridoxamine, or a pharmaceutically acceptable salt thereof; and a pharmaceutically acceptable carrier, and methods for their use in limiting the progression of renal disease and / or diabetic complications in human diabetic patient.

Description

CROSS REFERENCE [0001] The present application claims priority to U.S. Provisional Patent Applications Ser. Nos. 60 / 480,032 filed Jun. 20, 2003 and 60 / 562,062 filed Apr. 14, 2004, each of which is hereby incorporated by reference in its entirety.BACKGROUND OF THE INVENTION [0002] Nephropathy develops in 30 to 40 percent of patients with Type 1 diabetes, and in an estimated 10 to 15 percent of patients with Type 2 diabetes. An early sign of the disease includes the loss of protein (particularly albumin) into the urine (“proteinuria” or “albuminuria”). As renal damage progresses, patients lose the ability to effectively filter the blood in the glomerulus and can progress to the need for dialysis or transplantation. Diabetic nephropathy, and in particular dialysis and transplantation, is costly both in terms of medical treatment and in lost productivity. Treatment that prevents or limits the development or progression of diabetic nephropathy will meet a significant medical need and pro...

Claims

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Application Information

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IPC IPC(8): A61K31/44A61K31/4412A61K45/06A61P3/10A61P13/00
CPCA61K31/44A61K31/4412A61K45/06A61K2300/00A61P13/00A61P3/10
Inventor DEGENHARDT, THORSTENSCHOTZINGER, ROBERTFOX, WESLEY J.
Owner NEPHROGENEX
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