Pyridoxamine for the treatment of diabetic kidney disease
a technology of pyridoxamine and kidney disease, which is applied in the direction of peptide/protein ingredients, extracellular fluid disorder, metabolic disorder, etc., can solve the problems of diabetic nephropathy, dialysis and transplantation, and loss of productivity, so as to and limit the progression of renal disease and/or diabetic complications.
Inactive Publication Date: 2006-12-21
NEPHROGENEX
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- Claims
- Application Information
AI Technical Summary
Benefits of technology
The use of pyridoxamine compositions effectively reduces the progression of renal disease and diabetic complications, as evidenced by decreased serum creatinine levels and urinary albumin excretion, thereby potentially reducing the need for dialysis or transplantation.
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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[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% PY...
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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 Application 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 prov...
Claims
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IPC IPC(8): A61K31/4415A61K38/28A61K31/401A61K31/366A61K31/22A61K31/44A61K31/4412A61K45/06A61P3/10A61P13/00
CPCA61K31/44A61K31/4412A61K45/06A61K2300/00A61P13/00A61P3/10
Inventor DEGENHARDT, THORSTENSCHOTZINGER, ROBERTFOX, WESLEY J.
Owner NEPHROGENEX