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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015821-34 | EudraCT Number |
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Study hypothesis: Nicotinamide inhibits gastrointestinal phosphate absorption and serum phosphate levels of dialysis patients in a dose dependent manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 250 mg/d modified release Nicotinamide | Experimental |
| |
| 500 mg/d modified release Nicotinamide | Experimental |
| |
| 750 mg/d modified release Nicotinamide | Experimental |
| |
| 1000 mg/d modified release Nicotinamide | Experimental |
| |
| 1000 mg/d immidiate release Nicotinamide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotinamide | Drug | dosage |
|
| Measure | Description | Time Frame |
|---|---|---|
| serum phosphate | 4 weeks of active treatment |
| Measure | Description | Time Frame |
|---|---|---|
| serum phosphate | 8 weeks of active treatment | |
| serum calcium | 4 and 8 weeks of acitve treatment | |
| serum PTH |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walter Zidek, Prof. Dr. | Charité Berlin, Campus Benjamin Franklin, Innere Medizinische Klinik IV WE 28 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alsfeld | 36304 | Germany | ||||
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| 4 and 8 weeks of active treatment |
| adverse events | 12 weeks |
| Arnstadt |
| 99310 |
| Germany |
| Augsburg | 86157 | Germany |
| Berlin | 12045 | Germany |
| Berlin | 12203 | Germany |
| Berlin | 12435 | Germany |
| Berlin | 13051 | Germany |
| Bielefeld | 33602 | Germany |
| Coburg | 96450 | Germany |
| Darmstadt | 64295 | Germany |
| Dortmund | 44135 | Germany |
| Dülmen | 48249 | Germany |
| Düsseldorf | 40210 | Germany |
| Elsenfeld | 63820 | Germany |
| Erfurt | 99089 | Germany |
| Essen | 45127 | Germany |
| Friedrichsroda | 99894 | Germany |
| Hamburg | 22297 | Germany |
| Hamelin | 31787 | Germany |
| Hellersdorf | 12627 | Germany |
| Herne | 44623 | Germany |
| Herzberg | 04916 | Germany |
| Iserlohn | 58638 | Germany |
| Jena-Drakendorf | 07751 | Germany |
| Kamen | 59174 | Germany |
| Kreuzberg | 10245 | Germany |
| Leverkusen | 51373 | Germany |
| Mannheim | 68309 | Germany |
| Minden | 32429 | Germany |
| Nordhausen | 99734 | Germany |
| Osnabrück | 49074 | Germany |
| Pfarrkirchen | 84347 | Germany |
| Regensburg | 93053 | Germany |
| Schwabach | 91126 | Germany |
| Tangermünde | 39590 | Germany |
| Wuppertal | 42283 | Germany |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D009536 | Niacinamide |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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