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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT No.: 2006-001787-23 |
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This study will evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Chronic Kidney Disease patients on hemodialysis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 1g tid |
|
| 2 | Active Comparator | Sevelamer HCl |
|
| 3 | Experimental | SBR759 1.5 g tid |
|
| 4 | Active Comparator | Sevelamer HCl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBR759 | Drug | Starting dose of 1g or 1.5g tid, with an increase of 1g tid every 2 weeks until serum phosphate level fall below target. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Responder rates in target serum phosphate levels at 12 weeks Evaluate efficacy of SBR759 compared to sevelamer HCl at 12 weeks | Time Frame: 12 weeks + 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Responder rates in target patients with serum calcium-phosphate levels at 12 weeks/12 months | Time Frame: 12 weeks / 12 months |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | Chula Vista | California | 91910 | United States | ||
| Novartis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21854503 | Result | 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. |
| Label | URL |
|---|---|
| Results for CSBR759A2201 from the Novartis Clinical Trials Website | View source |
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| Sevelamer HCl | Drug | 0.8 g tid |
|
| SBR759 | Drug | 1.5 g tid |
|
| Sevelamer HCl | Drug | 1.6 g tid |
|
| La Mesa |
| California |
| 91942 |
| United States |
| Novartis | Whittier | California | 90602 | United States |
| Novartis | Denver | Colorado | 80262 | United States |
| Novartis | North Chicago | Illinois | 60064 | United States |
| Novartis | Peoria | Illinois | 61602 | United States |
| Novartis | Mishawaka | Indiana | 46545 | United States |
| Novartis | Baltimore | Maryland | 21287 | United States |
| Novartis | Fall River | Massachusetts | 02720 | United States |
| Novartis | Springfield | Massachusetts | 01104 | United States |
| Novartis Investigative Site | Omaha | Nebraska | 68144 | United States |
| Novartis | New York | New York | 10032 | United States |
| Novartis | Winston-Salem | North Carolina | 27157-1082 | United States |
| Novarits | Fargo | North Dakota | 58103 | United States |
| Novartis | Portland | Oregon | 97210 | United States |
| Novartis | Pittsburgh | Pennsylvania | 15224 | United States |
| Novartis Investigative Site | Houston | Texas | 77024 | United States |
| Novartis | San Antonio | Texas | 78207 | United States |
| Novartis | Fairfax | Virginia | 22031 | United States |
| Novartis | Adelaide | South Australia | Australia |
| Novartis | Fitzroy | Victoria | Australia |
| Novartis | Parkville | Victoria | 3052 | Australia |
| Novartis | Melbourne | 3065 | Australia |
| Novartis | South Brisbane | Australia |
| Novartis | Woolloongabba | 4102 | Australia |
| Novartis Investigative Site | Antwerp | Belgium |
| Novartis | Bruges | 8000 | Belgium |
| Novartis | Brussels | 1000 | Belgium |
| Novartis | Liège | 4000 | Belgium |
| Novartis Investigative Site | Saint Niklaas | Belgium |
| Novartis Investigative Site | Edmonton | Canada |
| Novartis Investigative Site | London | Canada |
| Novartis Investigative Site | Oshawa | Canada |
| Novartis Investigative Site | Québec | Canada |
| Novartis | Helsinki | 00100 | Finland |
| Novartis | Oulu | 90100 | Finland |
| Novartis | Tampere | 33100 | Finland |
| Novartis | Turku | 20100 | Finland |
| Novartis | Amiens | 80054 | France |
| Novartis | Fleury-Mérogis | France |
| Novartis | Lyon | 69446 | France |
| Novartis | Reims | 51685 | France |
| Novartis | Salouël | 80480 | France |
| Novartis Investigative Site | Berlin | Germany |
| Novartis Investigative Site | Coburg | Germany |
| Novartis Investigative Site | Lecco | Italy |
| Novartis Investigative Site | Lodi | Italy |
| Novartis Investigative Site | Milan | Italy |
| Novartis Investigative Site | Modena | Italy |
| Novartis Investigative Site | Pavia | Italy |
| Novartis | Bergen | 5011 | Norway |
| Novartis | Kristiansand | 1001 | Norway |
| Novartis | Oslo | 0027 | Norway |
| Novartis | Tønsberg | Norway |
| Novartis | San Juan | 00927 | Puerto Rico |
| Novartis Investigative Site | Jönköping | Sweden |
| Novartis Investigative Site | Karlstad | Sweden |
| Novartis Investigative Site | Skövde | Sweden |
| Novartis Investigative Site | Stockholm | Sweden |
| Novartis | Aarau | 5000 | Switzerland |
| Novartis | Lausanne | 1011 | Switzerland |
| Novartis | Zurich | 8091 | Switzerland |
| Novartis | Hull | United Kingdom |
| Novartis Investigative Site | Manchester | United Kingdom |
| Novartis Investigative Site | Portsmouth | United Kingdom |
| Novartis | Salford | United Kingdom |
| 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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