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Generated: March 25, 2019

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CLINICAL TRIALS PROFILE FOR SEVELAMER CARBONATE

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Clinical Trials for Sevelamer Carbonate

Trial ID Title Status Sponsor Phase Summary
NCT00151918 Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease Completed Shire Phase 3 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
NCT00267514 Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer HCl Tablets in Haemodialysis Patients Completed Genzyme, a Sanofi Company Phase 3 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 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.
NCT00364000 Arterial Stiffness and Calcifications in Haemodialysis Patients on Sevelamer or Calcium Acetate Unknown status Romanian Society of Nephrology N/A End-stage renal disease (ESRD) is a state of increased arterial stiffness of extensive vessel calcifications, compared with the non-renal population. Both arterial stiffness and arterial calcifications are potent predictors of all-cause and cardiovascular mortality in ESRD patients. Several studies have documented the direct relationship between the extent and severity of arterial/coronary calcifications and outcome in dialysis patients. The relationship is strong no matter if arterial calcifications were quantified by electron-beam computed tomography or a radiological calcification score. Calcifications are early and progressive events in these patients. PWV is strongly related to the degree of sonographic determined arterial calcifications and EBCT-derived coronary artery calcium score in chronic kidney disease patients. Calcium-based phosphate binders are associated with progressive coronary artery and aortic calcification, especially when mineral metabolism is not well controlled. According to recent studies, sevelamer hydrochloride is a potent non-calcium-containing phosphate binder, well tolerated in ESRD. Compared with calcium-based phosphate binders, sevelamer is less likely to cause hypercalcemia, low levels of PTH, and progressive coronary and aortic calcification in hemodialysis patients. Moreover, sevelamer has a favorable effect on the lipid profile. Less is known about the relationship between sevelamer treatment and progression of arterial stiffness. To date, there is one single study examining the influence of sevelamer (versus calcium carbonate) on the evolution of arterial stiffness in a very small number (N=15) of haemodialysis patients. These study used the same patients as historical controls, thus being methodologically rather weak. Moreover, the follow-up was quite short - 6 month. The aim of the trial is to to quantify, in a randomized opened-labeled controlled trial the effect of sevelamer hydrochloride on the evolution of arterial stiffness parameters (pulse wave velocity and the augmentation index) in chronic haemodialysis patients and to correlate these parameters with arterial calcification assessed by a previous described radiological score of arterial calcification and echocardiographic parameters (left ventricular hypertrophy, LV dilatation, systolic and diastolic dysfunction).
NCT00440648 Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate Completed Genzyme, a Sanofi Company Phase 2 This is a double-blind, randomized, cross-over study conducted at centers within the United States. The study consists of five periods: an up to two-week Screening Period, a 5-week Run-In Period, two eight-week study treatment periods and a two-week Washout Period. Patients are assigned randomly (1:1) to one of two treatment sequences: sevelamer carbonate for eight weeks followed by sevelamer hydrochloride for eight weeks or sevelamer hydrochloride for eight weeks followed by sevelamer carbonate for eight weeks
NCT00441545 Head to Head Study Against Sevelamer Hydrochloride Completed Shire Phase 3 To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Sevelamer Carbonate

Condition Name

Condition Name for Sevelamer Carbonate
Intervention Trials
Chronic Kidney Disease 15
Hyperphosphatemia 10
Kidney Failure, Chronic 4
Hyperphosphataemia 2
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Condition MeSH

Condition MeSH for Sevelamer Carbonate
Intervention Trials
Kidney Diseases 31
Renal Insufficiency, Chronic 28
Hyperphosphatemia 13
Kidney Failure, Chronic 9
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Clinical Trial Locations for Sevelamer Carbonate

Trials by Country

Trials by Country for Sevelamer Carbonate
Location Trials
United States 129
Germany 7
United Kingdom 6
France 5
Italy 5
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Trials by US State

Trials by US State for Sevelamer Carbonate
Location Trials
New York 11
California 10
Colorado 8
Illinois 7
Florida 7
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Clinical Trial Progress for Sevelamer Carbonate

Clinical Trial Phase

Clinical Trial Phase for Sevelamer Carbonate
Clinical Trial Phase Trials
Phase 4 4
Phase 3 16
Phase 2 9
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Clinical Trial Status

Clinical Trial Status for Sevelamer Carbonate
Clinical Trial Phase Trials
Completed 30
Recruiting 6
Not yet recruiting 3
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Clinical Trial Sponsors for Sevelamer Carbonate

Sponsor Name

Sponsor Name for Sevelamer Carbonate
Sponsor Trials
Genzyme, a Sanofi Company 17
Shire 7
Fresenius Medical Care North America 4
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Sponsor Type

Sponsor Type for Sevelamer Carbonate
Sponsor Trials
Industry 37
Other 25
NIH 2
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