(-2.5, -1.5)
 -2.1* 

(-2.6, -1.7)
 
*  p<0.0001, within treatment group comparison
Figure 2. Cumulative percentage of patients (Y-axis) attaining a phosphorus change from baseline (mg/dL) at least as great as the value of the X-axis. A shift to the left of a curve indicates a better response.
Average daily sevelamer hydrochloride dose at the end of treatment was 4.9 g (range of 0.0 to 12.6 g).

Cumulative percentage of patients (Y-axis) attaining a phosphorus change from baseline (mg/dL) at least as great as the value of the X-axis. A shift to the left of a curve indicates a better response. 14.4 Sevelamer Hydrochloride Versus Active-Control in Hemodialysis Patients
Two hundred CKD patients on hemodialysis who were hyperphosphatemic (serum phosphorus > 5.5 mg/dL) following a two-week phosphate binder washout period were randomized to receive sevelamer hydrochloride 800 mg tablets (N=99) or an active-control (N=101). At week 52, using last-observation-carried-forward, sevelamer and active-control both significantly decreased mean serum phosphorus (Table 5).

Table 5.  Mean Serum Phosphorus (mg/dL) and Ion Product at Baseline and Change from Baseline to End of Treatment  Sevelamer
 HCl
(N=94) Active-Control
(N=98)
Phosphorus
Baseline
Change from Baseline at
Endpoint
 7.5

-2.1
 7.3

-1.8
 
Ca x Phosphorus Ion Product
Baseline
Change from Baseline at
Endpoint
 70.5

-19.4
 68.4

-14.2

Sixty-one percent of sevelamer hydrochloride patients and 73% of the control patients completed the full 52 weeks of treatment.

Figure 3, a plot of the phosphorus change from baseline for the completers, illustrates the durability of response for patients who are able to remain on treatment.

Figure 3. Mean Phosphorus Change from Baseline for Patients who Completed 52 Weeks of Treatment

Average daily sevelamer hydrochloride dose at the end of treatment was 6.5 g (range of 0.8 to 13 g).

Mean Phosphorus Change from Baseline for Patients who Completed 52 Weeks of Treatment 14.5 Sevelamer Hydrochloride Versus Active-Control in Peritoneal Dialysis Patients
One hundred and forty-three patients on peritoneal dialysis who were hyperphosphatemic (serum phosphorus > 5.5 mg/dL) following a two-week phosphate binder washout period were randomized to receive sevelamer hydrochloride (N=97) or active-control (N=46) open label for 12 weeks. Average daily sevelamer hydrochloride dose at the end of treatment was 5.9 g (range 0.8 to 14.3 g). Thirteen patients (14%) in the sevelamer group and 9 patients (20%) in the active-control group discontinued, mostly for gastrointestinal adverse reactions. There were statistically significant changes in serum phosphorus (p<0.001) for sevelamer hydrochloride (-1.6 mg/dL from baseline of 7.5 mg/dL), similar to the active-control.

14.6 Once a Day Versus Three Times a Day Dosing
Stage 5 CKD patients on hemodialysis with a serum phosphate level of > 5.5 mg/dL after washout from baseline therapies were randomized in a 2:1 ratio to receive either sevelamer carbonate powder once-daily (N=144) or sevelamer hydrochloride as a tablet with the dose divided T