An Open Label Dose Titration of Sevelamer Carbonate Tabs 3 Times a Day in Hyperphosphatemic CKD Patients Not On Dialysis

Inclusion Criteria

• •A minimum of 120 male and female patients with chronic kidney disease not requiring dialysis will be screened for participation in the study.
• •Men or woman 18 years of age or older
• •If currently taking phosphate binder(s), willing to stop this and enter a 2 week washout period
• •Willing to avoid any intentional changes in diet such as fasting or dieting
• •Have the following central laboratory measurements: 1. If not on a phosphate binder, a serum phosphorus measurement ≥ 5.5 mg/dL (1.76 mmol/L) at Screening (Visit1). 2. If taking a phosphate binder(s) at screening, a serum phosphorus measurement ≥ 5.5 mg/dL (1.76 mmol/L) after the two-week washout period at Visit 1a (Day 0).
• •At Screening (Visit 1), have the following central laboratory measurements: 1. 25-hydroxyvitamin D ≥ 10 ng/mL 2. iPTH ≤ 800 pg/mL
• •Willing and able to take sevelamer carbonate alone as a phosphate binder for the duration of the study
• •Willing and able to maintain screening doses of lipid medication, 1,25 dihydroxyvitamin D, and/or cinacalcet 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 study, which includes barrier methods, hormones, or IUDs
• •Expecting not to initiate dialysis for the duration of this study
• •Considered compliant with phosphate binders (if applicable)
• •Willing and able to provide informed consent
• •Has 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