Renagel (Page 4 of 5)

14 CLINICAL STUDIES

The ability of Renagel to lower serum phosphorus in CKD patients on dialysis was demonstrated in six clinical trials: one double-blind placebo controlled 2-week study (Renagel N=24); two open-label uncontrolled 8-week studies (Renagel N=220) and three active-controlled open-label studies with treatment durations of 8 to 52 weeks (Renagel N=256). Three of the active-controlled studies are described here. One is a crossover study with two 8-week periods comparing Renagel to an active-control. The second is a 52-week parallel study comparing Renagel with active-control. The third is a 12-week parallel study comparing Renagel and active-control in peritoneal dialysis patients.

14.1 Active-Control, Cross-Over Study in Hemodialysis Patients

Eighty-four CKD patients on hemodialysis who were hyperphosphatemic (serum phosphorus > 6.0 mg/dL) following a two-week phosphate binder washout period received Renagel and active-control for eight weeks each in random order. Treatment periods were separated by a two-week phosphate binder washout period. Patients started on treatment three times per day with meals. Over each eight-week treatment period, at three separate time points the dose of Renagel could be titrated up 1 capsule or tablet per meal (3 per day) to control serum phosphorus, the dose of active-control could also be altered to attain phosphate control. Both treatments significantly decreased mean serum phosphorus by about 2 mg/dL (Table 4).

Table 4. Mean Serum Phosphorus (mg/dL) at Baseline and Endpoint
Renagel® (N=81) Active-Control (N=83)
*
p<0.0001, within treatment group comparison

Baseline at End of Washout

8.4

8.0

Change from Baseline at Endpoint

(95% Confidence Interval)

-2.0*

(-2.5, -1.5)

-2.1*

(-2.6, -1.7)

Figure 2 shows that the proportion of patients achieving a given level of serum phosphorus lowering is similar in the two treatment groups. Median decrease in phosphorus was 2 mg/dL on each treatment.

Figure 2. Cumulative percent of patients (Y-axis) attaining a phosphorus change from baseline at least as great as the value of the X-axis. A shift to the left of a curve indicates a better response.

Figure 2. Cumulative percent of patients (Y-axis) attaining a phosphorus change from baseline at least as great as the value of the X-axis. A shift to the left of a curve indicates a better response.
(click image for full-size original)

Average daily Renagel dose at the end of treatment was 4.9 g (range of 0.0 to 12.6 g).

14.2 Active-Control, Parallel Study 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 Renagel 800 mg tablets (N=99) or an active-control (N=101). The two treatments produced similar decreases in serum phosphorus. At week 52, using last-observation-carried-forward, Renagel 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
Renagel® (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 Renagel 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

Figure 3. Mean Phosphorus Change from Baseline for Patients who Completed 52 Weeks of Treatment
(click image for full-size original)

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

14.3 Active-Control, Parallel Study 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 Renagel® (N=97) or active-control (N=46) open label for 12 weeks. Average daily Renagel dose at the end of treatment was 5.9 g (range 0.8 to 14.3 g). There were statistically significant changes in serum phosphorus (p<0.001) for Renagel (-1.6 mg/dL from baseline of 7.5 mg/dL), similar to the active-control.

16 HOW SUPPLIED/STORAGE AND HANDLING

Renagel® 800 mg Tablets are supplied as oval, film-coated, compressed tablets, imprinted with “RENAGEL 800” containing 800 mg of sevelamer hydrochloride on an anhydrous basis, hypromellose, diacetylated monoglyceride, colloidal silicon dioxide, and stearic acid.

Renagel® 400 mg Tablets are supplied as oval, film-coated, compressed tablets, imprinted with “RENAGEL 400” containing 400 mg of sevelamer hydrochloride on an anhydrous basis, hypromellose, diacetylated monoglyceride, colloidal silicon dioxide, and stearic acid.

They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-0777-1 800 mg 30 Tablets in a Blister Pack WHITE 58468-0021

Storage Store at 25°C (77°F): excursions permitted to 15-30°C (59-86°F).

Do not use Renagel® after the expiration date on the bottle.

[See USP controlled room temperature]

Protect from moisture.

Distributed by:

Genzyme Corporation
500 Kendall Street
Cambridge, MA 02142 USA

Manufactured by:

Genzyme Ireland Ltd.

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States

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