Latest research on Sevelamer

Sevelamer is a phosphate binding drug used to prevent hyperphosphataemia in patients with chronic renal failure. When taken with meals, sevelamer binds to dietary phosphate and prevents its absorption. It is marketed by Genzyme under the trade name Renagel.

Sevelamer dosage

Later, a Phase II, randomized, active-controlled, multi-center, open-label, dose-finding study (NCT00824460) was designed to evaluate efficacy and safety of different dosages of sucroferric oxyhydroxide (1.25, 5.0, 7.5, 10.0, or 12.5 g/day) as compared to Sevelamer hydrochloride (4.8 g/day) for 6 weeks in a cohort of 154 hemodialysis patients. [source, 2016]
Serum phosphate significantly decreased in all groups except that receiving sucroferric oxyhydroxide 1.25 g/day; in particular, the 5 g/day and 7.5 g/day dosages were as efficacious as 4.8 g/day of Sevelamer hydrochloride. [source, 2016]
Subjects were randomized to receive sucroferric oxyhydroxide 1.0–3.0 g/day (n=707) and Sevelamer 4.8–14.4 g/day (n=348) according to the following scheme of therapy: an 8-week period for dose titration, 4 weeks without changing the doses, and a 12-week phase of maintenance treatment. [source, 2016]
Afterwards, 644 eligible patients of this trial were enrolled for a 28-week open-label Phase III extension study (NCT01464190)57 during which they continued to receive the same treatment at the same dose as at the end of the first study (n=384 sucroferric oxyhydroxide; n=260 Sevelamer). [source, 2016]
The design of the initial study has been described previously [15]; in brief, after 2–4 weeks of washout from previous phosphate binders, eligible patients with serum phosphorus concentrations ≥1.94 mmol/L were randomized (2:1) to receive sucroferric oxyhydroxide [1.0−3.0 g/day (2−6 tablets/day); n = 710] or Sevelamer carbonate [‘Sevelamer’ 2.4−14.4 g/day (3−18 tablets/day), starting dose 4.8 g/day; n = 349]. [source, 2015]
Overall, 466 patients (515 patients who completed Stage 1 of the initial Phase III study minus 49 low-dose sucroferric oxyhydroxide patients excluded after Stage 2) receiving sucroferric oxyhydroxide and 293 patients receiving Sevelamer completed the initial study and were eligible for the extension study (Figure 2). [source, 2015]
We did not analyze the changes in Sevelamer dose or CBPB dose in different treatment phases. [source, 2015]
Chen et al8 performed a randomized, double-blind, dose-titration study which compared Sevelamer carbonate (starting dose 800 mg three times daily) with placebo over 8 weeks’ duration in Chinese CKD patients on HD. [source, 2015]
The combination treatment of Sevelamer, pulse doses of active Vitamin D, and other treatments can significantly decrease iPTH for SHPT patients, with little occurrence of hypercalcemia, hyperphosphatemia, and metastatic calcification.43–46 [source, 2015]
The starting dose of Sevelamer was 2.4 g/day (i.e. 3 tablets) if serum phosphorus was ≤2.42 mmol/L (7.5 mg/dL) or 4.8 g/day (i.e. 6 tablets) if serum phosphorus was >2.42 mmol/L (7.5 mg/dL), with titration up or down between 2.4 and 12 g/day. [source, 2014]