Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-01-08 @ 4:09 AM
Study NCT ID:
NCT00320060
Status:
COMPLETED
Last Update Posted:
2006-04-27
First Post:
2006-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pyridorin in Patients With Diabetic Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570561', 'term': 'pyridoxamine dihydrochloride'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-10'}, 'statusVerifiedDate': '2006-04', 'completionDateStruct': {'date': '2003-01'}, 'lastUpdateSubmitDate': '2006-04-27', 'studyFirstSubmitDate': '2006-04-27', 'studyFirstSubmitQcDate': '2006-04-27', 'lastUpdatePostDateStruct': {'date': '2006-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Diabetic nephropathy', 'Advanced Glycation Endproduct Inhibitor', 'Pyridorin', 'Pyridoxamine'], 'conditions': ['Diabetic Nephropathy']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the safety and tolerability of Pyridorin (pyridoxamine dihydrochloride) 50 mg given orally twice daily in patients with diabetic kidney disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and Females (non-pregnant and non-lactating) between 18 and 70 years of age with type 1 or type 2 diabetes\n* Sitting blood pressure of \\<=170/100 mm Hg at weeks -2 and -1\n* Hemoglobin A1C \\<=12% at week -2\n* Patients with diagnosis of diabetic nephropathy as defined by\n\n 1. Serum Creatinine \\<=2.0 mg/dL at weeks -2 and -1\n 2. Urinary albumin excretion \\>=300 mg/24 hours at week -2\n 3. Diagnosis of diabetic retinopathy\n* Creatinine clearance \\>=40 mL/min at weeks -2 and -1\n* Voluntary written consent to participate in this study\n\nExclusion Criteria:\n\n* History of allergic or adverse response to any B vitamin\n* History of major cardiovascular or cerebrovascular events\n* History of cancer except adequately treated basal or squamous cell carcinoma of the skin\n* History of diabetic ketoacidosis'}, 'identificationModule': {'nctId': 'NCT00320060', 'briefTitle': 'Effect of Pyridorin in Patients With Diabetic Nephropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioStratum'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, 24-Week Study to Evaluate the Safety and Tolerability of Pyridorin (Pyridoxamine Dihydrochloride) in Patients With Diabetic Nephropathy Associated With Type 1 or Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'PYR-206'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pyridorin (pyridoxamine dihydrochloride)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Thorsten P Degenhardt, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'BioStratum, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioStratum', 'class': 'INDUSTRY'}}}}