A Phase 3 interventional study of Sevelamer carbonate (Renvela®) and Sevelamer hydrochloride (Renagel®) in Kidney Diseases, Chronic Renal Insufficiency and End-Stage Renal Disease, sponsored by Genzyme, a Sanofi Company. Completed at 29 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-19.
Sponsored by Genzyme, a Sanofi Company · Phase 3, Interventional, and Treatment
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 217 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Genzyme, a Sanofi Company is the lead sponsor of 303 studies on the registry; 5 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.
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Exclusion Criteria:
sevelamer carbonate powder
Drug: Sevelamer carbonate (Renvela®)
Sevelamer hydrochloride
Drug: Sevelamer hydrochloride (Renagel®)
sevelamer carbonate powder dosed once per day with largest meal
Sevelamer hydrochloride tablets dosed three times a day with meals
Demonstrate the efficacy of sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets dosed TID with meals on the control of serum phosphorus
Time frame: Up to 24 weeks
Evaluate the safety and tolerability of sevelamer carbonate powder dosed QD with the largest meal compared to sevelamer hydrochloride tablets dosed TID with meals
Time frame: Up to 24 weeks
Compare sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets TID with meals on serum calcium-phosphorus product and serum lipid profile
Time frame: Up to 24 weeks
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Genzyme, a Sanofi Company