A Randomized, Parallel, Open-Label Study to Compare Once-Daily Sevelamer Carbonate Powder Dosing With Thrice-Daily Sevelamer Hydrochloride Tablet Dosing in CKD Patients on Hemodialysis
A Randomized, Parallel, Open-Label Study to Compare Once-Daily Sevelamer Carbonate Powder Dosing With Thrice-Daily Sevelamer Hydrochloride Tablet Dosing in CKD Patients on Hemodialysis
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DOI：
10.1053/j.ajkd.2009.10.051
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发表时间：
2010-02-01
影响因子：
13.2
通讯作者：
Moe, Sharon
中科院分区：
文献类型：
--
作者：
Fishbane, Steven;Delmez, James;Moe, Sharon
Background: Sevelamer carbonate powder for oral suspension is a new dosage form of sevelamer, which may be suited to once-daily dosing.Study Design: Randomized parallel open-label study.Setting & Participants: Hemodialysis patients.Intervention: After a 2-week phosphate-binder washout, patients were randomly assigned to once-daily sevelamer carbonate powder or thrice-daily sevelamer hydrochloride tablets.Outcomes: Assessment of noninferiority with respect to change from baseline in serum phosphorus levels.Measurements: Serum phosphorus to 24 weeks.Results: After washout, mean serum phosphorus level decreased 2.0 +/- 1.8 mg/dL (from 7.3 +/- 1.3 mg/dL) for sevelamer carbonate and 2.9 +/- 1.3 mg/dL (from 7.6 +/- 1.3 mg/dL) for sevelamer hydrochloride (both P < 0.001). The upper CI bound was 1.50 mg/dL; therefore, noninferiority was not shown. 54% of sevelamer carbonate powder-treated patients and 64% of sevelamer hydrochloride tablet-treated patients had serum phosphorus levels within the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI) target (>= 3.5 and
