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sevelamer carbonate sevelamer · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | OTHER | sevelamer carbonate powder x 4 weeks then, sevelamer hydrochloride x 4 weeks |
| 2 | OTHER | sevelamer hydrochloride x 4 weeks then, sevelamer carbonate powder x 4 weeks |
| Name | Type | Description |
|---|---|---|
| sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®) | DRUG | sevelamer carbonate powder dosed TID with meals for four weeks followed by sevelamer hydrochloride tablets dosed TID with meals for four weeks |
| sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®) | DRUG | sevelamer hydrochloride tablets dosed TID with meals for four weeks followed by sevelamer carbonate powder dosed TID with meals for four weeks |
Inclusion Criteria: * Receiving three times per week haemodialysis for three months or longer. * Taking sevelamer hydrochloride alone (e.g. not using other types of phosphate binders concomitantly) or on combination therapy (e.g. using sevelamer hydrochloride and calcium containing, or metal phosph...
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Sevelamer carbonate and sevelamer hydrochloride are used in chronic kidney disease, specifically for patients on haemodialysis. They are phosphate binders taken with meals to control serum phosphorus levels. The Phase 3 trial NCT00267514 studied these uses in chronic kidney disease patients.
Sanofi develops and markets sevelamer carbonate and sevelamer hydrochloride. Sanofi trades under the ticker SNY. The products are sold as Renvela (sevelamer carbonate) and Renagel (sevelamer hydrochloride).
Sevelamer carbonate (Renvela) and sevelamer hydrochloride (Renagel) are related forms of the same active ingredient, sevelamer. Sevelamer carbonate is the carbonate salt and sevelamer hydrochloride is the hydrochloride salt. Both are used in chronic kidney disease and were compared in the Phase 3 equivalence study NCT00267514.
Sevelamer carbonate and sevelamer hydrochloride have completed Phase 3 clinical development. The Phase 3 trial NCT00267514, which compared sevelamer carbonate powder with sevelamer HCl tablets in haemodialysis patients, is completed. No active trials are currently listed for this asset.
Sevelamer carbonate and sevelamer hydrochloride were studied in the Phase 3 trial NCT00267514, titled Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer HCl Tablets in Haemodialysis Patients. It enrolled 31 participants in the United Kingdom, was controlled and randomized, and is completed.
Sevelamer carbonate and sevelamer hydrochloride are small molecule phosphate binders. They bind phosphate in the gastrointestinal tract to reduce its absorption, which lowers serum phosphorus levels in chronic kidney disease patients on haemodialysis. This mechanism supports their use in managing hyperphosphatemia.