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Approximately 207 patients with chronic kidney disease (CKD) on hemodialysis will be entered into this study at approximately 26 centers in the United States. This study aims to evaluate the safety and efficacy of sevelamer carbonate powder dosed once-a-day (QD) with the largest meal compared to sevelamer hydrochloride tablets dosed three-times-per-day (TID) with meals. The total length of participation is approximately 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | sevelamer carbonate powder |
|
| 2 | Active Comparator | Sevelamer hydrochloride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevelamer carbonate (RenvelaĀ®) | Drug | sevelamer carbonate powder dosed once per day with largest meal |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate the efficacy of sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets dosed TID with meals on the control of serum phosphorus | Up to 24 weeks | |
| Evaluate the safety and tolerability of sevelamer carbonate powder dosed QD with the largest meal compared to sevelamer hydrochloride tablets dosed TID with meals | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Compare sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets TID with meals on serum calcium-phosphorus product and serum lipid profile | Up to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center | Birmingham | Alabama | 35213 | United States | ||
| Gadsden Dialysis |
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| Sevelamer hydrochloride (RenagelĀ®) |
| Drug |
Sevelamer hydrochloride tablets dosed three times a day with meals |
|
| Gadsden |
| Alabama |
| 35901 |
| United States |
| Holy Cross Renal Care | Mission Hills | California | 91345 | United States |
| Nephrology Educational Services and Research | Tarzana | California | 91356 | United States |
| Crystal Rivers Dialysis Center | Crystal River | Florida | 34429 | United States |
| Outcomes Research International, Inc. | Hudson | Florida | 34667 | United States |
| Central Dialysis Center | Atlanta | Georgia | 30329 | United States |
| Atlanta Nephrology Referral Center | Decatur | Georgia | 30030 | United States |
| FMC Marietta | Marietta | Georgia | 30066 | United States |
| Horizon Healthcare Associates | Flossmoor | Illinois | 60422 | United States |
| Indiana University Hospital | Indianapolis | Indiana | 46202 | United States |
| Ochsner Clinic Foundation, Nephrology Research | New Orleans | Louisiana | 70121 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Southwest Mississippi Nephrology, PLLC | Brookhaven | Mississippi | 39601 | United States |
| Nephrology Associates, P.C. | Columbus | Mississippi | 39705 | United States |
| Nephrology & Hypertension Associates, LTD | Tupelo | Mississippi | 38801 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Hypertension and Nephrology Associates | Eatontown | New Jersey | 07724 | United States |
| Winthrop University Dialysis Center | Mineola | New York | 11501 | United States |
| Davita | The Bronx | New York | 10461 | United States |
| Kidney and Hypertension Center | Cincinnati | Ohio | 45220 | United States |
| Renal Care Group | Cleveland | Ohio | 44109 | United States |
| Lewiston Dialysis Center | Lewistown | Pennsylvania | 17044 | United States |
| Medical Nephrology Associates | Dyersburg | Tennessee | 38024 | United States |
| Nephrology Associates, P.C. | Nashville | Tennessee | 37205 | United States |
| Renal Research Inc. at the Kidney Institute | Houston | Texas | 77054 | United States |
| Gambro Healthcare - Charlottesville | Charlottesville | Virginia | 22902 | United States |
| Clinical Research of Tidewater | Norfolk | Virginia | 23507 | United States |
| Virginia Commonwealth University, Division of Nephrology | Richmond | Virginia | 23298 | United States |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D007676 | Kidney Failure, Chronic |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051437 | Renal Insufficiency |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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