CLINICAL TRIALS PROFILE FOR FOSRENOL
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All Clinical Trials for FOSRENOL
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00160121 ↗ | Efficacy and Safety of Fosrenol in Treating Elevated Serum Phosphate Levels in Adults With End Stage Renal Disease | Completed | Shire | Phase 4 | 2005-01-10 | The purpose of this study is to test how well lanthanum carbonate reduces the pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease and to determine the patient and physician's satisfaction. |
| NCT00234702 ↗ | Efficacy and Safety of Lanthanum Carbonate in Reducing Serum Phosphorus Levels in Subjects With Stage 3 and 4 Chronic Kidney Disease | Completed | Shire | Phase 2 | 2006-01-11 | Chronic kidney disease (CKD) can result in a loss of ability to filter and excrete phosphate. The body's attempt to adjust to an increased level of phosphate in the blood can result in elevated levels of hormones and minerals resulting in serious clinical consequences. This study is being conducted to evaluate the safety and efficacy of lanthanum carbonate in lowering high levels of phosphorus in the blood in subjects with CKD Stages 3 and 4 compared to placebo. |
| NCT00441545 ↗ | Head to Head Study Against Sevelamer Hydrochloride | Completed | Shire | Phase 3 | 2007-01-05 | To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline. |
| NCT00452478 ↗ | Conversion From Standard Phosphate Binder Therapy to Fosrenol® (Lanthanum Carbonate) in Chronic Kidney Disease Stage 5 | Terminated | Shire | Phase 4 | 2007-05-22 | The main aim of this research study is to see if giving Fosrenol®, a chewable tablet, to patients on haemodialysis works as well as other treatments currently used to lower blood phosphorus levels. |
| NCT00557323 ↗ | Long-term Effect of Lanthanum Carbonate on Bone | Completed | Shire | 2007-03-15 | Patients enrolled in a previous study (SPD405-309), who were exposed to lanthanum carbonate (Fosrenol), were eligible to continue on any prescribed treatment for hyperphosphatemia, including lanthanum carbonate (Fosrenol), for an additional 5 years. Patients were being observed for any bone adverse events or other serious adverse events, as well as the collection of mortality data. | |
| NCT00660530 ↗ | Chewed vs. Crushed Lanthanum Carbonate in Hemodialysis Patients | Completed | Shire | Phase 2 | 2008-01-01 | Patients with end-stage renal disease (ESRD) commonly develop hyperphosphatemia due to the loss of excretory function of the kidney. This in turn may lead to the development of secondary hyperparathyroidism (SHPT) and renal osteodystrophy. Lanthanum carbonate, a phosphate binding agent, works by releasing lanthanum ions in the gastrointestinal tract to bind dietary phosphate and is effective in the management of hyperphosphatemia and in preventing secondary hyperparathyroidism. Patients taking lanthanum carbonate as part of their phosphate binder therapy are counseled to chew the tablets completely before swallowing, with or immediately after meals. However, ESRD patients who are intubated or are receiving enteral tube feedings are unable to chew the lanthanum carbonate tablets. For such patients, medications are commonly crushed and administered through a gastrostomy tube (G-tube). Some patients may also prefer to crush the lanthanum carbonate tablets and mix it with food instead of chewing. To date, it is not known if crushing the lanthanum carbonate tablets prior to administration and taking it with food will be as efficacious as chewing it. The objective of this study is to compare the efficacy of phosphate binding between chewed and crushed lanthanum carbonate in patients undergoing hemodialysis. |
| NCT00660530 ↗ | Chewed vs. Crushed Lanthanum Carbonate in Hemodialysis Patients | Completed | University of Illinois at Chicago | Phase 2 | 2008-01-01 | Patients with end-stage renal disease (ESRD) commonly develop hyperphosphatemia due to the loss of excretory function of the kidney. This in turn may lead to the development of secondary hyperparathyroidism (SHPT) and renal osteodystrophy. Lanthanum carbonate, a phosphate binding agent, works by releasing lanthanum ions in the gastrointestinal tract to bind dietary phosphate and is effective in the management of hyperphosphatemia and in preventing secondary hyperparathyroidism. Patients taking lanthanum carbonate as part of their phosphate binder therapy are counseled to chew the tablets completely before swallowing, with or immediately after meals. However, ESRD patients who are intubated or are receiving enteral tube feedings are unable to chew the lanthanum carbonate tablets. For such patients, medications are commonly crushed and administered through a gastrostomy tube (G-tube). Some patients may also prefer to crush the lanthanum carbonate tablets and mix it with food instead of chewing. To date, it is not known if crushing the lanthanum carbonate tablets prior to administration and taking it with food will be as efficacious as chewing it. The objective of this study is to compare the efficacy of phosphate binding between chewed and crushed lanthanum carbonate in patients undergoing hemodialysis. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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