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This is a randomized, open-label, parallel-design study to be conducted at 75 centers within the United States. The study will be described to hemodialysis patients. Informed consent will be obtained and the inclusion/exclusion criteria reviewed. Eligible patients will be randomized to receive either Renagel or a calcium-based binder.
Starting from the randomization date, mortality data including survival, death date and cause of death (vital status information) and morbidity data including hospitalization date will be recorded for all patients. These data will be collected until the end of the study (December 31, 2004, ± 2 weeks). Patients completing or terminating from the study will return to the phosphate binder prescribed by their usual healthcare provider.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevelamer hydrochloride | Drug | |||
| Calcium-based phosphate binder | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy will be evaluated based on a comparison of the association of Renagel use versus calcium-based phosphate binder use on all-cause mortality, cause-specific mortality (cardiovascular, infection, other), and all-cause hospitalization. | ||
| Safety will be assessed based on an evaluation of related serious adverse events. |
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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 |
|---|---|---|---|---|---|---|
| Gambro Healthcare-Gadsden | Gadsden | Alabama | United States | |||
| nTouch Research |
| 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. |
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| Huntsville |
| Alabama |
| United States |
| Kidney Health Institute, LLC | Tucson | Arizona | United States |
| Gambro Healthcare | El Cerrito | California | United States |
| Palomar Medical Group | Escondido | California | United States |
| Gambro Healthcare-Los Angeles | Los Angeles | California | United States |
| Balboa Nephrology Medical Group | San Diego | California | United States |
| Nephrology Educational Services and Research | Tarzana | California | United States |
| Lowry Dialysis Center | Denver | Colorado | United States |
| Nephrology Associates, P.C. | Bridgeport | Connecticut | United States |
| Gambro Healthcare-Hartford | Hartford | Connecticut | United States |
| Nephrology Associates | New Britain | Connecticut | United States |
| InterAmerican Dialysis | Coral Gables | Florida | United States |
| DaVita Crystal River Dialysis | Crystal River | Florida | United States |
| Gambro Healthcare-Miami | Miami | Florida | United States |
| Miami Kidney Group | Miami | Florida | United States |
| Pensacola Nephrology, P.A. | Pensacola | Florida | United States |
| Gambro Healthcare-Plantation | Plantation | Florida | United States |
| America Dialysis | St. Petersburg | Florida | United States |
| Genesis Clinical Research Corp | Tampa | Florida | United States |
| Gambro Healthcare-Americus | Americus | Georgia | United States |
| nTouch Research | Atlanta | Georgia | United States |
| Gambro Healthcare-Douglas | Douglas | Georgia | United States |
| Gambro Healthcare-Douglasville | Douglasville | Georgia | United States |
| Dublin Nephrology | Dublin | Georgia | United States |
| Georgia Kidney Associates, Inc. | Marietta | Georgia | United States |
| Gambro Healthcare-Rome | Rome | Georgia | United States |
| Gambro Healthcare-Savannah | Savannah | Georgia | United States |
| MacNeal Renal Lifeline Services | Berwyn | Illinois | United States |
| Southwest Nephrology | Evergreen Park | Illinois | United States |
| Horizon Healthcare Associates | Olympia Fields | Illinois | United States |
| Renal Care Associates, S.C. | Peoria | Illinois | United States |
| Gambro Healthcare-Springfield Central | Springfield | Illinois | United States |
| Lincolnland Dialysis | Springfield | Illinois | United States |
| Nephrology Specialists, PC. | Valparaiso | Indiana | United States |
| Wichita Dialysis Center East | Wichita | Kansas | United States |
| Wichita Nephrology | Wichita | Kansas | United States |
| Northwest Louisiana Nephrology, LLC. | Shreveport | Louisiana | United States |
| BMA of Washington | Bethesda | Maryland | United States |
| Gambro Healthcare-Frederick | Frederick | Maryland | United States |
| Associates in Nephrology, P.C. | Brockton | Massachusetts | United States |
| Western New England Renal and Transplant Associates, Inc. | Springfield | Massachusetts | United States |
| DaVita Clinical Research | Minneapolis | Minnesota | United States |
| Nephrology Associates, P.C. | Columbus | Mississippi | 39705 | United States |
| University of Missouri-Kansas City | Kansas City | Missouri | United States |
| DaVita Crystal City Dialysis | St Louis | Missouri | United States |
| Nephrology and Endocrine Associates | Las Vegas | Nevada | United States |
| Bronx Westchester Medical Group | The Bronx | New York | United States |
| Mountain Kidney Associates, P.A. | Asheville | North Carolina | United States |
| nTouch Research | Raleigh | North Carolina | United States |
| Wake Nephrology/Wake Dialysis Clinic | Raleigh | North Carolina | United States |
| Gambro Healthcare-Wilson | Wilson | North Carolina | United States |
| Kidney and Hypertension Center | Cincinnati | Ohio | 45220 | United States |
| Ohio State University College of Pharmacy | Columbus | Ohio | United States |
| FMC of Bethlehem | Allentown | Pennsylvania | United States |
| Fresenius Medical Care | Greensburg | Pennsylvania | United States |
| Hypertension and Kidney Specialists | Lancaster | Pennsylvania | United States |
| DaVita Lewistown Dialysis Center | Lewistown | Pennsylvania | United States |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| P.C. & Associates | Philadelphia | Pennsylvania | United States |
| Nesbitt College of Pharmacy and Nursing Department of Pharmacy Practice | Wilkes-Barre | Pennsylvania | United States |
| Gambro Healthcare-Aiken | Aiken | South Carolina | United States |
| Midsouth Nephrology Consultants | Memphis | Tennessee | United States |
| Dallas Nephrology Associates | Dallas | Texas | United States |
| Nephrology, Dialysis and Transplant Association | Houston | Texas | United States |
| West Houston Dialysis | Houston | Texas | United States |
| San Antonio Kidney Disease Center | San Antonio | Texas | United States |
| Gambro Healthcare - Charlottesville | Charlottesville | Virginia | 22902 | United States |
| Clinical Research and Consulting Center, LLC | Fairfax | Virginia | United States |
| Clinical Research of Tidewater | Norfolk | Virginia | 23507 | United States |
| Virginia Commonwealth University, Division of Nephrology | Richmond | Virginia | 23298 | United States |
| Vancouver Clinic Inc., P.S. | Vancouver | Washington | United States |
| Clinical Las Americas | San Juan | Puerto Rico |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| 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 |
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| ID | Term |
|---|---|
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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