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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pyridorin (pyridoxamine dihydrochloride) | Drug |
Inclusion Criteria:
Males and Females (non-pregnant and non-lactating) between 18 and 70 years of age with type 1 or type 2 diabetes
Sitting blood pressure of <=170/100 mm Hg at weeks -2 and -1
Hemoglobin A1C <=12% at week -2
Patients with diagnosis of diabetic nephropathy as defined by
Creatinine clearance >=40 mL/min at weeks -2 and -1
Voluntary written consent to participate in this study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thorsten P Degenhardt, Ph.D. | BioStratum, Inc. | Study Director |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C570561 | pyridoxamine dihydrochloride |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |