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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006097-15 | EudraCT Number |
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This study will compare placebo to 4 different doses of SBR759 to assess the phosphate lowering efficacy in dialysis patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Placebo Comparator | Placebo |
|
| Arm 3 | Experimental |
| |
| Arm 2 | Experimental |
| |
| arm 4 | Experimental | SBR759A |
|
| arm 5 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBR759A | Drug | SBR759A 6g daily |
| |
| SBR759A |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate changes in serum phosphate during a 2 week random treatment withdrawal period of SBR759 after 4 weeks treatment | 6 weeks | |
| Evaluate dose-dependent efficacy of SBR759 | 6 weeks | |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Jette | 1090 | Belgium | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40576086 | Derived | Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4. | |
| 23670305 | Derived | Fukagawa M, Kasuga H, Joseph D, Sawata H, Junge G, Moore A, Akiba T. Efficacy and safety of SBR759, a novel calcium-free, iron (III)-based phosphate binder, versus placebo in chronic kidney disease stage V Japanese patients on maintenance renal replacement therapy. Clin Exp Nephrol. 2014 Feb;18(1):135-43. doi: 10.1007/s10157-013-0815-7. Epub 2013 May 15. |
| Label | URL |
|---|---|
| Results for CSBR759A2304 from the Novartis Clinical Trials website | View source |
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| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D051437 | Renal Insufficiency |
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| Drug |
Placebo Comparator 0g daily |
|
| SBR759A | Drug | SBR759A 3g daily |
|
| SBR759A | Drug | 9g daily |
|
| SBR759A | Drug | 12g daily |
|
| Compare the short-term safety profile and dose-dependent tolerability of SBR759 dosed with meals taken 3 times a day to that of placebo |
| 6 weeks |
| Liège |
| 4000 |
| Belgium |
| Novartis Investigative Site | Roeselare | 8800 | Belgium |
| Novartis Investigative Site | Brescia | 25123 | Italy |
| Novartis Investigative Site | Lecco | 23900 | Italy |
| Novartis Investigator Site | Lucca | 55100 | Italy |
| Novartis Investigative Site | Naples | 80131 | Italy |
| Novartis Investigative Site | Pavia | 27100 | Italy |
| Novartis Investigative Site | Siena | 53100 | Italy |
| 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 |