Advertisement

Topics

Open Label Tolerability and Safety Study of KRX-101 in Australia, New Zealand, and Hong Kong

2014-08-27 03:39:03 | BioPortfolio

Summary

The purpose of this study is to assess the tolerability and safety of KRX-101 in treating persistent microalbuminuria in type 2 diabetic patients who are also being treated with stable, maximum tolerated doses of either ACE inhibitors or A2 receptor blockers.

Description

Diabetes is one of the most common causes of end-stage renal disease (ESRD) in the U.S. and in many other developed nations. Despite advances in clinical care, including improvements in glycemic and blood pressure control, the number of new cases of diabetes-related ESRD continues to rise, especially in patients with type 2 diabetes.

The current standard of care for the prevention and treatment of diabetic renal disease includes screening all diabetic patients for microalbuminuria. Patients who test positive for microalbuminuria are then treated with either ACE inhibitors or A2 receptor blockers. Both of these classes of medication have been shown to reduce levels of microalbuminuria in some patient populations. This improvement in microalbuminuria has also shown a delay of progression to a number of other renal function problems, as well as a minimal delay in certain clinical events including ESRD.

Unfortunately, some patients achieve the majority of their therapeutic effect of ACE inhibitors or A2 receptor blockers within the first 6 months of therapy, and many of these patients continue to show persistent microalbuminuria. Therefore, these patients are at an increased risk of progressing to ESRD due to the lack of adequate benefit from their current medication.

Microalbuminuria has a straight-line relationship with adverse renal outcomes; therefore any level of reduction may have clinical benefit. It is reasonable to believe that patients who can reduce or have a complete remission of their microalbuminuria may also lessen the risk of progressing to ESRD. Thus, if KRX-101 is able to cause a reduction or complete remission of microalbuminuria to normoalbuminuria, patients may receive a significant clinical benefit.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Diabetic Nephropathy

Intervention

sulodexide

Location

Monash Medical Center
Melbourne
Victoria
Australia
3168

Status

Terminated

Source

Keryx Biopharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:39:03-0400

Clinical Trials [1115 Associated Clinical Trials listed on BioPortfolio]

Effect of Sulodexide in Overt Diabetic Nephropathy

The purpose of this study is to determine whether sulodexide is effective in slowing or preventing the progression of diabetic kidney disease.

Effect of Sulodexide in Early Diabetic Nephropathy

The purpose of the study is to determine whether treatment with sulodexide is effective in reducing the level of urine albumin excretion in patients with early diabetic kidney disease expr...

Sulodexide Treatment in Patients With Dense Deposit Disease

The purpose of this study is to see if a medicine called Sulodexide will help prevent or slow down the progression of Membranoproliferative Glomerulonephritis type II/Dense Deposit Disease...

Effects of PH3 in Diabetic Nephropathy

The primary objective of this clinical study is to evaluate the effectiveness and safety of PH3 for patients with diabetic nephropathy. The secondary objectives are to identify the optima...

The Efficacy and Safety Study of Sulodexide in Filipino Diabetic Patients With Chronic Kidney Disease

The purpose of this study is to determine the effect and safety of Sulodexide in Filipino patients with Chronic Kidney Disease (CKD).

PubMed Articles [1638 Associated PubMed Articles listed on BioPortfolio]

Diabetic nephropathy: is it always there? Assumptions, weaknesses and pitfalls in the diagnosis.

Diabetic nephropathy is defined as a microvascular complication of the kidneys induced by diabetes mellitus and is characterized by albuminuria and progressive loss of kidney function. However, neithe...

Clinicopathological analysis of biopsy-proven diabetic nephropathy based on the Japanese classification of diabetic nephropathy.

The Japanese classification of diabetic nephropathy reflects the risks of mortality, cardiovascular events and kidney prognosis and is clinically useful. Furthermore, pathological findings of diabetic...

Advances in early biomarkers of diabetic nephropathy.

Diabetic nephropathy is the main cause of chronic kidney disease, and represents the most common and serious complication of diabetes. The exact pathogenesis is complex and not elucidated. Several fac...

Effect of post-transplant glycemic control on long-term clinical outcomes in kidney transplant recipients with diabetic nephropathy: A multicenter cohort study in Korea.

Diabetic nephropathy is the leading cause of end stage renal disease. The number of kidney transplantation (KT) due to diabetic nephropathy is increasing and there is debate on glycemic control after ...

Angiopoietin-2, Renal Deterioration, Major Adverse Cardiovascular Events and All-Cause Mortality in Patients with Diabetic Nephropathy.

Diabetic nephropathy is the leading cause of end-stage renal disease and accounts for 30∼40% of patients requiring maintenance dialysis, thereby increasing the burden on health insurance programs. D...

Medical and Biotech [MESH] Definitions

Peripheral, autonomic, and cranial nerve disorders that are associated with DIABETES MELLITUS. These conditions usually result from diabetic microvascular injury involving small blood vessels that supply nerves (VASA NERVORUM). Relatively common conditions which may be associated with diabetic neuropathy include third nerve palsy (see OCULOMOTOR NERVE DISEASES); MONONEUROPATHY; mononeuropathy multiplex; diabetic amyotrophy; a painful POLYNEUROPATHY; autonomic neuropathy; and thoracoabdominal neuropathy. (From Adams et al., Principles of Neurology, 6th ed, p1325)

Renal syndrome in human immunodeficiency virus-infected patients characterized by nephrotic syndrome, severe proteinuria, focal and segmental glomerulosclerosis with distinctive tubular and interstitial changes, enlarged kidneys, and peculiar tubuloreticular structures. The syndrome is distinct from heroin-associated nephropathy as well as other forms of kidney disease seen in HIV-infected patients.

Common foot problems in persons with DIABETES MELLITUS, caused by any combination of factors such as DIABETIC NEUROPATHIES; PERIPHERAL VASCULAR DISEASES; and INFECTION. With the loss of sensation and poor circulation, injuries and infections often lead to severe foot ulceration, GANGRENE and AMPUTATION.

A phenylacetamide that was formerly used in ANALGESICS but nephropathy and METHEMOGLOBINEMIA led to its withdrawal from the market. (From Smith and Reynard, Textbook of Pharmacology,1991, p431)

A form of chronic interstitial nephritis that is endemic to limited areas of BULGARIA, the former YUGOSLAVIA, and ROMANIA. It is characterized by a progressive shrinking of the KIDNEYS that is often associated with uroepithelial tumors.

More From BioPortfolio on "Open Label Tolerability and Safety Study of KRX-101 in Australia, New Zealand, and Hong Kong"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Diabetes
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The two main types of diabetes are: type 1 diabetes type 2 diabetes In the UK, diabetes affects approximately 2.9 million people. There are a...


Searches Linking to this Trial