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| ID | Type | Description | Link |
|---|---|---|---|
| PYR-205 | |||
| PYR-207 |
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The primary objective of the study is to evaluate the safety, tolerability and efficacy of Pyridorin (pyridoxamine dihydrochloride) up to 250 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Creatinine from baseline to week 26 |
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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
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 |