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Sponsors and Collaborators: |
NephroGenex, Inc. The Collaborative Study Group Medpace |
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Information provided by: | NephroGenex, Inc. |
ClinicalTrials.gov Identifier: | NCT00734253 |
The primary objective of this study is to evaluate the efficacy of two different doses of Pyridorin (150 mg and 300 mg)compared to placebo in retarding the progression of diabetic nephropathy. This will be assessed by measuring the change in serum creatinine and other biomarkers of kidney disease during the course of the 1-year study.
Condition | Intervention | Phase |
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Diabetic Nephropathy |
Drug: Pyridoxamine Dihydrochloride Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 2b Study to Evaluate the Safety and Efficacy of Pyridorin (Pyridoxamine Dihydrochloride) in Patients With Nephropathy Due to Type 2 Diabetes |
Estimated Enrollment: | 300 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Pyridorin 150 mg bid
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Drug: Pyridoxamine Dihydrochloride
150 mg capsules taken orally twice a day for 1-year.
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2: Experimental
Pyridorin 300 mg bid
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Drug: Pyridoxamine Dihydrochloride
300 mg capsules taken twice a day for 1-year.
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3: Placebo Comparator
Placebo bid
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Drug: Placebo
Placebo capsules taken twice a day for 1-year
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Diabetic kidney disease afflicts about 20% of all diabetics and is the major cause of end-stage renal disease (ESRD). There are an estimated 1.2 million diabetic overt nephropathy patients in the US, and approximately 5.1 million diabetic patients exhibiting signs of developing kidney disease.
Hyperglycemia-induced microvascular disease is the fundamental cause of diabetic kidney disease. More specifically, hyperglycemia perturbs metabolic pathways, particularly in tissues that do not regulate intracellular glucose levels. This favors a broad range of pathogenic oxidative chemistries including the formation of advanced glycation end-products (AGEs), toxic carbonyls, and reactive oxygen species (ROS) that are considered to be the principal causative factors in the development of diabetic microvascular disease.
Pyridorin™ has been shown to inhibit AGE formation and to scavenge ROS and toxic carbonyl compounds in extensive in vitro studies. The therapeutic potential of Pyridorin™ has been demonstrated in vivo by extensive preclinical studies that have been carried out in a number of independent laboratories by prominent investigators. In addition, Pyridorin™ has demonstrated a significant treatment effect in slowing the progression of diabetic nephropathy in two Phase 2 clinical trials. Thus, a solid scientific rationale and clinical evidence exists for the application of Pyridorin™ therapy to slow the progression of diabetic kidney disease.
NephroGenex is initiating a new Phase 2b clinical trial (PYR-210) that is evaluating the safety and efficacy of Pyridorin™ in slowing the progression of overt nephropathy in patients with type 2 diabetes. This trial incorporates the latest discussion with the FDA regarding the use of an approvable surrogate marker that would be subsequently confirmed with hard clinical endpoints.
In this double-blind, placebo-controlled study, eligible type 2 diabetic patients with overt nephropathy will be treated for one year with bid doses of either Pyridorin™ 150 mg, Pyridorin™ 300 mg, or placebo. The primary endpoint in the study is the change in serum creatinine (SCr) from baseline after 1 year of therapy. Secondary
1-year endpoints include the slope of SCr, the change in protein/creatinine ratio (PCR) derived from 24-hour urine collections, and the change from baseline and slope of serum cystatin C.
The patient population studied will be type 2 diabetics with overt nephropathy defined as having a SCr between 1.3 and 3.3 mg/dl in females and between 1.5 and 3.5 mg/dl in males, accompanied by proteinuria in the macroalbuminuric range (PCR at least 1200 mg/g). In order to reduce confounding variables, careful control of blood pressure (BP) will be required. If not yet controlled, each patient's BP will brought to a level that the investigator believes is appropriate for the patient prior to randomization, and this will remain the target BP for that patient for the remainder of the study. Also, patients will be permitted to be on only one ACE inhibitor or angiotensin receptor blocker (ARB) and no other drugs that inhibit the renin-angiotensin-aldosterone axis throughout the study. A run-in period will be required in some patients to achieve the BP and ACEi/ARB requirements.
This study will be conducted with the leadership of the Collaborative Study Group.
Ages Eligible for Study: | 25 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
At the Screening Visit, ALL patients must have a history of overt diabetic nephropathy, as defined by the following:
At the Qualifying Visit (only applies to those patients who enter into the Optional Run-in Period), the following eligibility parameters must be met in order to be randomized:
EXCLUSION CRITERIA:
United States, Illinois | |
The Collaborative Study Group | |
Chicago, Illinois, United States, 60607 |
Study Chair: | Edmund J. Lewis, MD | Collaborative Study Group |
Responsible Party: | Chief Medical Officer, NephroGenex, Inc. ( Mark A. Klausner, MD ) |
Study ID Numbers: | PYR-210 |
Study First Received: | August 12, 2008 |
Last Updated: | August 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00734253 History of Changes |
Health Authority: | United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; Israel: Ministry of Health |
Nephropathy Kidney Disease Diabetes Pyridoxamine |
Pyridorin NephroGenex PYR-210 |
Vitamin B Complex Diabetic Nephropathies Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Trace Elements Pyridoxamine Urologic Diseases |
Vitamins Diabetes Mellitus, Type 2 Micronutrients Kidney Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Diabetes Complications |
Diabetic Nephropathies Metabolic Diseases Vitamin B Complex Growth Substances Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Pyridoxamine |
Pharmacologic Actions Urologic Diseases Vitamins Diabetes Mellitus, Type 2 Kidney Diseases Micronutrients Glucose Metabolism Disorders Diabetes Complications |