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Hyperphosphatemia clinical trials

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NCT ID: NCT00681941 Completed - Clinical trials for Chronic Kidney Disease

An Open Label Dose Titration of Sevelamer Carbonate Tabs 3 Times a Day in Hyperphosphatemic CKD Patients Not On Dialysis

Start date: January 2006
Phase: Phase 3
Study type: Interventional

Approximately 45 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 20 sites within Europe and 5-10 in Australia. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is an effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 14 weeks.

NCT ID: NCT00660530 Completed - Kidney Disease Clinical Trials

Chewed vs. Crushed Lanthanum Carbonate in Hemodialysis Patients

Start date: January 2008
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT00648167 Completed - Clinical trials for End-stage Renal Disease

A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)

Start date: March 2008
Phase: Phase 2
Study type: Interventional

This study is to evaluates the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease.

NCT ID: NCT00583570 Completed - Hyperphosphatemia Clinical Trials

Phosphorus Improvement Pilot Study

Start date: May 2007
Phase: N/A
Study type: Interventional

Specific Aim: To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels. Hypothesis: Educating dialysis patients regarding phosphate containing additives will result in improved serum phosphorus levels.

NCT ID: NCT00567723 Completed - Hyperphosphatemia Clinical Trials

Long Term Treatment of End Stage Renal Disease Patients With Lanthanum Carbonate (Fosrenol)

Start date: April 25, 2006
Phase:
Study type: Observational

Patients who have been treated with Fosrenol for a minimum of 12 consecutive weeks and are receiving dialysis will be followed for 5 years to compare mortality, bone fractures and incidence of selected morbidities to patients with no lanthanum exposure and to patients being treated for hyperphosphatemia with any marketed product.

NCT ID: NCT00557323 Completed - Hyperphosphatemia Clinical Trials

Long-term Effect of Lanthanum Carbonate on Bone

Start date: March 15, 2007
Phase:
Study type: Observational

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.

NCT ID: NCT00542815 Completed - Clinical trials for Chronic Kidney Disease

A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

Start date: November 2007
Phase: Phase 3
Study type: Interventional

This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks

NCT ID: NCT00542386 Completed - Clinical trials for Chronic Kidney Disease

A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia

Start date: December 2007
Phase: Phase 3
Study type: Interventional

This is a phase III multi-centre study in two periods: the first period is a phosphate binder and lipid lowering drugs washout for 8 weeks, the second period is a double-blind, randomised, parallel group, fixed dose, for 12 weeks.

NCT ID: NCT00530114 Completed - Clinical trials for Chronic Kidney Disease

Study to Assess Fixed Dosing of AMG 223 in Subjects With Chronic Kidney Disease on Hemodialysis With Hyperphosphatemia

Start date: March 2008
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are the following: 1. To demonstrate that AMG 223 will produce a statistically significant reduction in serum phosphorus compared with placebo over a 3 week treatment period in subjects with CKD receiving dialysis 2. To describe a dose response for AMG 223 3. To evaluate the safety and tolerability of AMG 223

NCT ID: NCT00508885 Completed - Hyperphosphatemia Clinical Trials

The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients

Start date: October 2006
Phase: Phase 1/Phase 2
Study type: Interventional

Hyperphosphatemia is common in the peritoneal dialysis population. Current strategies are insufficient to optimize phosphorus control. Animal studies have shown niacinamide, a form of vitamin B, to reduce phosphate uptake by the rat small intestine. Our trial investigates the use of niacinamide, in addition to standard phosphorus lowering strategies, to reduce plasma phosphorus levels in peritoneal dialysis patients versus placebo.