Chronic Kidney Disease Clinical Trial
Official title:
A Randomized, Open Label, Parallel Design Study of Renagel® Phosphate Binder Versus Calcium-Based Phosphate Binders in Hemodialysis Patients
| Verified date | March 2015 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 2000 |
| Est. completion date | February 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - patients must be 18 years of age or older, - on dialysis for more than 3 months, - require phosphate binder therapy, - have Medicare as their primary insurance. Exclusion Criteria: - dysphagia, - swallowing disorders, - severe gastrointestinal motility disorders, - bowel obstruction. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Clinical Las Americas | San Juan | |
| United States | Gambro Healthcare-Aiken | Aiken | South Carolina |
| United States | FMC of Bethlehem | Allentown | Pennsylvania |
| United States | Gambro Healthcare-Americus | Americus | Georgia |
| United States | Mountain Kidney Associates, P.A. | Asheville | North Carolina |
| United States | nTouch Research | Atlanta | Georgia |
| United States | MacNeal Renal Lifeline Services | Berwyn | Illinois |
| United States | BMA of Washington | Bethesda | Maryland |
| United States | Nephrology Associates, P.C. | Bridgeport | Connecticut |
| United States | Associates in Nephrology, P.C. | Brockton | Massachusetts |
| United States | Bronx Westchester Medical Group | Bronx | New York |
| United States | Gambro Healthcare - Charlottesville | Charlottesville | Virginia |
| United States | Kidney and Hypertension Center | Cincinnati | Ohio |
| United States | Nephrology Associates, P.C. | Columbus | Mississippi |
| United States | Ohio State University College of Pharmacy | Columbus | Ohio |
| United States | InterAmerican Dialysis | Coral Gables | Florida |
| United States | DaVita Crystal River Dialysis | Crystal River | Florida |
| United States | Dallas Nephrology Associates | Dallas | Texas |
| United States | Lowry Dialysis Center | Denver | Colorado |
| United States | Gambro Healthcare-Douglas | Douglas | Georgia |
| United States | Gambro Healthcare-Douglasville | Douglasville | Georgia |
| United States | Dublin Nephrology | Dublin | Georgia |
| United States | Gambro Healthcare | El Cerrito | California |
| United States | Palomar Medical Group | Escondido | California |
| United States | Southwest Nephrology | Evergreen Park | Illinois |
| United States | Clinical Research and Consulting Center, LLC | Fairfax | Virginia |
| United States | Gambro Healthcare-Frederick | Frederick | Maryland |
| United States | Gambro Healthcare-Gadsden | Gadsden | Alabama |
| United States | Fresenius Medical Care | Greensburg | Pennsylvania |
| United States | Gambro Healthcare-Hartford | Hartford | Connecticut |
| United States | Nephrology, Dialysis and Transplant Association | Houston | Texas |
| United States | West Houston Dialysis | Houston | Texas |
| United States | nTouch Research | Huntsville | Alabama |
| United States | University of Missouri-Kansas City | Kansas City | Missouri |
| United States | Hypertension and Kidney Specialists | Lancaster | Pennsylvania |
| United States | Nephrology and Endocrine Associates | Las Vegas | Nevada |
| United States | DaVita Lewistown Dialysis Center | Lewistown | Pennsylvania |
| United States | Gambro Healthcare-Los Angeles | Los Angeles | California |
| United States | Georgia Kidney Associates, Inc. | Marietta | Georgia |
| United States | Midsouth Nephrology Consultants | Memphis | Tennessee |
| United States | Gambro Healthcare-Miami | Miami | Florida |
| United States | Miami Kidney Group | Miami | Florida |
| United States | DaVita Clinical Research | Minneapolis | Minnesota |
| United States | Nephrology Associates | New Britain | Connecticut |
| United States | Clinical Research of Tidewater | Norfolk | Virginia |
| United States | Horizon Healthcare Associates | Olympia Fields | Illinois |
| United States | Pensacola Nephrology, P.A. | Pensacola | Florida |
| United States | Renal Care Associates, S.C. | Peoria | Illinois |
| United States | Albert Einstein Medical Center | Philadelphia | Pennsylvania |
| United States | P.C. & Associates | Philadelphia | Pennsylvania |
| United States | Gambro Healthcare-Plantation | Plantation | Florida |
| United States | nTouch Research | Raleigh | North Carolina |
| United States | Wake Nephrology/Wake Dialysis Clinic | Raleigh | North Carolina |
| United States | Virginia Commonwealth University, Division of Nephrology | Richmond | Virginia |
| United States | Gambro Healthcare-Rome | Rome | Georgia |
| United States | San Antonio Kidney Disease Center | San Antonio | Texas |
| United States | Balboa Nephrology Medical Group | San Diego | California |
| United States | Gambro Healthcare-Savannah | Savannah | Georgia |
| United States | Northwest Louisiana Nephrology, LLC. | Shreveport | Louisiana |
| United States | Gambro Healthcare-Springfield Central | Springfield | Illinois |
| United States | Lincolnland Dialysis | Springfield | Illinois |
| United States | Western New England Renal and Transplant Associates, Inc. | Springfield | Massachusetts |
| United States | DaVita Crystal City Dialysis | St. Louis | Missouri |
| United States | America Dialysis | St. Petersburg | Florida |
| United States | Genesis Clinical Research Corp | Tampa | Florida |
| United States | Nephrology Educational Services and Research | Tarzana | California |
| United States | Kidney Health Institute, LLC | Tucson | Arizona |
| United States | Nephrology Specialists, PC. | Valparaiso | Indiana |
| United States | Vancouver Clinic Inc., P.S. | Vancouver | Washington |
| United States | Wichita Dialysis Center East | Wichita | Kansas |
| United States | Wichita Nephrology | Wichita | Kansas |
| United States | Nesbitt College of Pharmacy and Nursing Department of Pharmacy Practice | Wilkes-Barre | Pennsylvania |
| United States | Gambro Healthcare-Wilson | Wilson | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Genzyme, a Sanofi Company |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | |||
| Primary | Safety will be assessed based on an evaluation of related serious adverse events. |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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