Safety and Efficacy Study of Pyridorin in Patients With Nephropathy Due to Type 2 Diabetes

NCT00734253 | Completed Phase 2 DMC

• 1 other identifier: PYR-210
• Study Type: interventional
• Target: 317
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Nephropathy

Keywords

Nephropathy; Kidney Disease; Diabetes; Pyridoxamine; Pyridorin; NephroGenex; PYR-210

Outcome Measures

Primary Outcomes (1)

• Change in serum creatinine from baseline to end of study.

  1 year

Secondary Outcomes (1)

• SCr slope, change in PCR, Cystatin C slope and change from baseline.

  1 Year

Study Arms (3)

1

EXPERIMENTAL

Pyridorin 150 mg bid

Drug: Pyridoxamine Dihydrochloride

2

EXPERIMENTAL

Pyridorin 300 mg bid

Drug: Pyridoxamine Dihydrochloride

3

PLACEBO COMPARATOR

Placebo bid

Drug: Placebo

Interventions

Pyridoxamine Dihydrochloride DRUG

150 mg capsules taken orally twice a day for 1-year.

1

Placebo DRUG

Placebo capsules taken twice a day for 1-year

3

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have given voluntary written consent to participate in this study prior to conducting Screening Visit procedures;
• Male and female patients 25 years of age or older with a diagnosis of type 2 diabetes; • If a woman is of childbearing potential (WOCBP) she must agree to use appropriate birth control (double barrier methods, hormonal contraceptives, or intrauterine device)for the duration of the study (WOCBP is defined as all women who are not surgically sterile or are not at least 1 year post-menopausal). All WOCBP must have a negative serum pregnancy test at the Screening Visit;
• At the Screening Visit, ALL patients must have a history of overt diabetic nephropathy, as defined by the following:
• A SCr measurement of 1.3 mg/dL to 3.3 mg/dL (women) or 1.5 mg/dL to 3.5 mg/dL (men) inclusive, and
• A 24-hour urine collection PCR ≥1200 mg/g;
• Patients must be receiving an ACE-I or an ARB, for at least 3 months prior to the Qualifying Visit (Screening Visit for those patients not entering into the Optional Run-in Period), where the dose of the ACE-I or the ARB is considered appropriate for that patient and has been stable for at least 2 months;
• Patients must be on stable blood pressure medications for 2 months prior to the Qualifying Visit (Screening Visit for those patients not entering into the Optional Run-in Period), with a seated blood pressure at the Qualifying Visit of ≤160/90 mmHg;
• 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:
• A SCr measurement within 25% of the SCr measurement at the Screening Visit; and
• A 24-hour urine collection PCR ≥600 mg/g.

You may not qualify if:

• Patients with type 1 diabetes;
• Patients with a diagnosis of chronic renal disease other than diabetic renal disease with or without hypertensive renal disease;
• Patients receiving a renin inhibitor or an aldosterone antagonist or a combination of an ACE-I and an ARB within 2 months of the Qualifying Visit (Screening Visit for those patients not entering into the Optional Run-in Period);
• Patients with a history of solid organ transplantation;
• Patients with a history of myocardial infarction, coronary re-vascularization procedures (including percutaneous transluminal coronary angioplasty), cerebrovascular accident ortransient ischemic attack within 1 month prior to the Screening Visit;
• Patients with a diagnosis of Class III or IV congestive heart failure at any time (as defined by the New York Heart Association);
• Patients with a history of neoplastic disease (except basal or squamous cell carcinoma of the skin) within 5 years prior to the Screening Visit;
• Patients with any history of dialysis within 2 years prior to the Screening Visit;
• Patients in whom dialysis or renal transplantation is anticipated by their physician within 1 year after the Screening Visit;
• Patients who used SCr altering drugs within 1 month prior to the Screening Visit;
• Patients who require systemic immunosuppression therapy for \>2 weeks (except for inhalant steroids);
• Patients with clinically significant liver disease or transaminase (alanine aminotransferase and aspartate aminotransferase) levels \>2.5 x upper limit of normal measured at the Screening Visit;
• Patients with bilirubin levels \>1.5 x upper limit of normal measured at the Screening Visit;
• Patients with a history of allergic or other adverse response to vitamin B preparations;
• Patients who require \>50 mg of vitamin B6 daily;

Sponsors & Collaborators

• NephroGenex, Inc.: lead
• Collaborative Study Group (CSG): collaborator
• Medpace, Inc.: collaborator

Study Sites (1)

The Collaborative Study Group

Chicago, Illinois, 60607, United States

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Kidney Diseases; Diabetes Mellitus

Interventions

pyridoxamine dihydrochloride

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Edmund J. Lewis, MD

  Collaborative Study Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 14, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 28, 2015

Record last verified: 2014-05

Locations

US (1)