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| Sponsor: | Genzyme |
|---|---|
| Information provided by: | Genzyme |
| ClinicalTrials.gov Identifier: | NCT00268957 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Diseases Chronic Renal Insufficiency End-Stage Renal Disease |
Drug: Sevelamer carbonate (Renvela®) Drug: Sevelamer hydrochloride (Renagel®) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Parallel, Open-Label Study to Compare Once Per Day Sevelamer Carbonate Powder Dosing With Three Times Per Day Sevelamer Hydrochloride Tablet Dosing in Chronic Kidney Disease Patients on Hemodialysis |
| Enrollment: | 217 |
| Study Start Date: | January 2006 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
sevelamer carbonate powder
|
Drug: Sevelamer carbonate (Renvela®)
sevelamer carbonate powder dosed once per day with largest meal
|
|
2: Active Comparator
Sevelamer hydrochloride
|
Drug: Sevelamer hydrochloride (Renagel®)
Sevelamer hydrochloride tablets dosed three times a day with meals
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Gadsden Dialysis | |
| Gadsden, Alabama, United States, 35901 | |
| Clinical Research Center | |
| Birmingham, Alabama, United States, 35213 | |
| United States, California | |
| Nephrology Educational Services and Research | |
| Tarzana, California, United States, 91356 | |
| Holy Cross Renal Care | |
| Mission Hills, California, United States, 91345 | |
| United States, Florida | |
| Crystal Rivers Dialysis Center | |
| Crystal River, Florida, United States, 34429 | |
| Outcomes Research International, Inc. | |
| Hudson, Florida, United States, 34667 | |
| United States, Georgia | |
| FMC Marietta | |
| Marietta, Georgia, United States, 30066 | |
| Central Dialysis Center | |
| Atlanta, Georgia, United States, 30329 | |
| Atlanta Nephrology Referral Center | |
| Decatur, Georgia, United States, 30030 | |
| United States, Illinois | |
| Horizon Healthcare Associates | |
| Flossmoor, Illinois, United States, 60422 | |
| United States, Indiana | |
| Indiana University Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Louisiana | |
| Ochsner Clinic Foundation, Nephrology Research | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| United States, Mississippi | |
| Nephrology Associates, P.C. | |
| Columbus, Mississippi, United States, 39705 | |
| Nephrology & Hypertension Associates, LTD | |
| Tupelo, Mississippi, United States, 38801 | |
| Southwest Mississippi Nephrology, PLLC | |
| Brookhaven, Mississippi, United States, 39601 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Hypertension and Nephrology Associates | |
| Eatontown, New Jersey, United States, 07724 | |
| United States, New York | |
| Winthrop University Dialysis Center | |
| Mineola, New York, United States, 11501 | |
| Davita | |
| Bronx, New York, United States, 10461 | |
| United States, Ohio | |
| Kidney and Hypertension Center | |
| Cincinnati, Ohio, United States, 45220 | |
| Renal Care Group | |
| Cleveland, Ohio, United States, 44109 | |
| United States, Pennsylvania | |
| Lewiston Dialysis Center | |
| Lewistown, Pennsylvania, United States, 17044 | |
| United States, Tennessee | |
| Nephrology Associates, P.C. | |
| Nashville, Tennessee, United States, 37205 | |
| Medical Nephrology Associates | |
| Dyersburg, Tennessee, United States, 38024 | |
| United States, Texas | |
| Renal Research Inc. at the Kidney Institute | |
| Houston, Texas, United States, 77054 | |
| United States, Virginia | |
| Virginia Commonwealth University, Division of Nephrology | |
| Richmond, Virginia, United States, 23298 | |
| Gambro Healthcare - Charlottesville | |
| Charlottesville, Virginia, United States, 22902 | |
| Clinical Research of Tidewater | |
| Norfolk, Virginia, United States, 23507 | |
| Study Director: | Medical Monitor | Genzyme |
More Information
| Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
| Study ID Numbers: | GD3-199-301 |
| Study First Received: | December 22, 2005 |
| Last Updated: | July 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00268957 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Chronic Hemodialysis Kidney |
Hyperphosphatemia Chronic kidney disease Chronic Renal Insufficiency |
|
Sevelamer Renal Insufficiency Molecular Mechanisms of Pharmacological Action Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Chelating Agents Kidney Diseases Pharmacologic Actions Kidney Failure |