CLINICAL TRIALS PROFILE FOR SEVELAMER HYDROCHLORIDE
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All Clinical Trials for Sevelamer Hydrochloride
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00018135 ↗ | Parathyroid Hormone Levels in Relation to the Phosphorus Content of Meals | Completed | National Center for Research Resources (NCRR) | N/A | 1969-12-31 | Patients on hemodialysis tend to have chronic elevations in the level of phosphorus in the blood and a secondary increase in the iPTH level. This chronic elevation in iPTH can have adverse consequences, thus a variety of phosphate binders are given in an attempt to decrease the absorption of phosphorus present in the normal diet. Some preliminary studies have indicated that the iPTH level may change based on the amount of phosphorus present in a meal prior to any significant absorption of phosphorus. If this is true in hemodialysis patients, then the timing of the administration of phosphate binders in relation to the ingestion of meals needs to be considered |
| NCT00151918 ↗ | Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease | Completed | Shire | Phase 3 | 2005-01-07 | The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with either lanthanum carbonate or sevelamer hydrochloride |
| NCT00196755 ↗ | Study of Safety and Efficacy of Renagel® Compared With Calcium Acetate in Patients With Peritoneal Dialysis | Completed | Genzyme, a Sanofi Company | Phase 3 | 2004-12-01 | The purpose of this study is to demonstrate that sevelamer hydrochloride is non-inferior to calcium acetate for the treatment of hyperphosphataemia in patients receiving peritoneal dialysis. |
| NCT00211939 ↗ | CARE-2 (Calcium Acetate [PhosLo®]/Sevelamer[Renagel®] Evaluation Study 2) for Heart Calcification in Dialysis Patients | Completed | Nabi Biopharmaceuticals | Phase 4 | 2005-01-01 | The purpose of the study is to evaluate the effects of two phosphate binders, PhosLo and sevelamer, on heart calcification in dialysis patients. The study will use a non-invasive technique, electron beam computed tomography (CT) scanning, to measure calcium in the coronary arteries, the aortic valve, and the mitral valve. |
| NCT00267514 ↗ | Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer HCl Tablets in Haemodialysis Patients | Completed | Genzyme, a Sanofi Company | Phase 3 | 2006-01-01 | The purpose of this study is to determine if sevelamer carbonate powder is an effective treatment for the control of serum phosphorous levels in patients on dialysis when compared to sevelamer hydrochloride tablets. |
| NCT00268957 ↗ | Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis | Completed | Genzyme, a Sanofi Company | Phase 3 | 2006-01-01 | 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. |
| NCT00324376 ↗ | Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing | Completed | Genzyme, a Sanofi Company | Phase 2 | 2003-03-01 | A randomized, cross-over, open-label study will be conducted to evaluate the equivalency, safety and tolerability of sevelamer once per day dosing, given with the largest meal, compared with standard three times per day dosing, in hemodialysis patients previously using sevelamer. Following a two week Run-In period, a total of 24 patients will be randomized to one of the following treatment sequences: 1. sevelamer dosed once a day with the largest meal followed by standard three times per day dosing with meals 2. sevelamer dosed three times per day with meals followed by once a day dosing with the largest meal. Patients will maintain a fixed daily dose throughout both treatment periods based on the most recently prescribed sevelamer dose prior to screening. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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