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This study will determine the titration regimen for SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Asian Chronic Kidney Disease patients on hemodialysis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 1g bid |
|
| 2 | Active Comparator | 0.8 g tid |
|
| 3 | Experimental | 1.5 g tid |
|
| 4 | Active Comparator | 1.6 g tid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBR759 | Drug | 1g tid |
| |
| Sevelamer HCl |
| Measure | Description | Time Frame |
|---|---|---|
| Responder rates achieving target serum phosphate levels. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Responder rates in target patients with serum calcium-phosphate levels. | Week 12 |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Kōriyama | Fukushima | Japan | |||
| 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. | |
| 21854503 | Derived | Chen JB, Chiang SS, Chen HC, Obayashi S, Nagasawa M, Hexham JM, Balfour A, Junge G, Akiba T, Fukagawa M. Efficacy and safety of SBR759, a novel calcium-free, iron(III)-based phosphate binder, in Asian patients undergoing hemodialysis: A 12-week, randomized, open-label, dose-titration study versus sevelamer hydrochloride. Nephrology (Carlton). 2011 Nov;16(8):743-50. doi: 10.1111/j.1440-1797.2011.01509.x. |
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| Drug |
1.6 g tid |
|
| Sevelamer HCl | Drug | 1.5 g tid |
|
| Sevelamer HCl | Drug | 0.8 g tid |
|
| Midori |
| Gunma |
| Japan |
| Novartis Investigative Site | Hitachiomiya | Ibaraki | Japan |
| Novartis Investigative Site | Moriya | Ibaraki | Japan |
| Novartis Investigative Site | Sashima-gun | Ibaraki | Japan |
| Novartis Investigative Site | Takamatsu | Kagawa-ken | Japan |
| Novartis Investigative Site | Tsu | Mie-ken | Japan |
| Novartis Investigative Site | Nagano | Nagano | Japan |
| Novartis Investigative Site | Okayama | Okayama-ken | Japan |
| Novartis Investigative Site | Sakai | Osaka | Japan |
| Novartis Investigative Site | Kasukabe | Saitama | Japan |
| Novartis Investigative Site | Shizuoka | Shizuoka | Japan |
| Novartis Investigative Site | Changhua | Taiwan |
| Novartis Investigative Site | Kaoshiung | Taiwan |
| Novartis Investigative Site | Taipei | Taiwan |
| 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 |
|---|---|
| C570356 | SBR 759 |
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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