Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis

Inclusion criteria

• On three times per week hemodialysis for three months or longer
• Currently on a phosphate binder(s)
• Considered compliant with phosphate binders and hemodialysis therapy
• Willing to avoid any intentional changes in diet such as fasting or dieting
• Have the following documented local laboratory measurements:a.Two most recent consecutive serum phosphorus measurements that are ≥ 3.0 and ≤ 6.5 (6.5) mg/dL within 60 days of screening; b.A most recent intact parathyroid hormone (iPTH) measurement ≤ 800 pg/mL within 90 days of screening
• Have the following central laboratory measurements: a.A serum phosphorus measurement > 5.5 mg/dL at randomization (Week 0);b.A serum iPTH measurement ≤ 800 pg/mL at screening
• Have not participated in any other investigational drug studies within 30 days prior to enrollment
• Level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel
• Willing and able to take sevelamer alone as a phosphate binder for the duration of the study
• Willing and able to maintain screening doses of lipid medication for the duration of the study, except for safety reasons
• Willing and able to avoid antacids and phosphate binders containing aluminum, magnesium, calcium or lanthanum for the duration of the study unless prescribed as an evening calcium supplement
• If female and of childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout the study, which includes barrier methods, hormones, or intrauterine devices (IUDs)
• Life expectancy of 12 months or greater
• Willing and able to provide informed consent

Exclusion criteria

• Active bowel obstruction, dysphagia, swallowing disorder, or severe gastrointestinal (GI) motility disorders
• Active ethanol or drug abuse, excluding tobacco use
• In the opinion of the Investigator, subject has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition
• Use of anti-arrhythmic or anti-seizure medications for the use of arrhythmia or seizure disorders
• Known hypersensitivity to sevelamer or any constituents of the study drug
• Pregnant or breast-feeding
• Evidence of active malignancy except for basal cell carcinoma of the skin
• Unable to comply with the requirements of the study
• Any other condition which, in the opinion of the Investigator, will prohibit the subject's inclusion in the study