A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease Patients Not on Dialysis (ASPIRE)

• To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum total cholesterol and low density lipoprotein (LDL) cholesterol [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
• To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum corrected calcium-phosphorus product (CaxP) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Approximately 207 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 50 sites within approximately 9 European countries. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is a safe and effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 24 weeks.

• Chronic Kidney Disease
• Hyperphosphatemia

• Drug: Sevelamer carbonate
  800mg tablets to be taken orally with meals three times per day
  Other Name: Renvela(TM)
• Drug: Placebo for sevelamer carbonate
  Placebo tablets to be taken orally with meals three times per day

• Active Comparator: Sevelamer carbonate
  Intervention: Drug: Sevelamer carbonate
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo for sevelamer carbonate

Inclusion Criteria:

• Serum phosphorus measurement ≥4.6 mg/dL (≥1.49 mmol/L) and ≤5.5 mg/dL (≤1.76 mmol/L after discontinuation of current phosphate binder therapy if applicable.

Exclusion Criteria:

• Active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation.