Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer HCl Tablets in Haemodialysis Patients

Inclusion Criteria:

• Receiving three times per week haemodialysis for three months or longer.

• Taking sevelamer hydrochloride alone (e.g. not using other types of phosphate bindersconcomitantly) or on combination therapy (e.g. using sevelamer hydrochloride andcalcium containing, or metal phosphate binders concomitantly) not exceeding a totaldaily binder dose of 14.4 g, for at least 60 days prior to screening.

• Have the following documented local laboratory measurements:

1. Two most recent consecutive serum phosphorus measurements that are ≥ 3.0 and ≤ 7.0 mg/dL (≥ 0.96 and ≤ 2.26 mmol/L) within 60 days of screening

2. An most recent iPTH measurement ≤ 900 pg/mL (< 99 pmol/L) within 90 days ofscreening

3. A most recent serum calcium (adjusted for albumin) measurement within normalrange defined by the local laboratory within 60 days of screening

• Have the following central laboratory measurements:

1. A serum phosphorus measurement ≥ 5.5 mg/dL (≥ 1.76 mmol/L) at Visit 2 (afterWashout)

2. A serum iPTH measurement ≤ 800 pg/mL at Visit 5 (prior to randomization)

3. A serum phosphorus measurement ≥ 3.0 and ≤ 6.5 mg/dL (≥ 0.96 and ≤ 2.08 mmol/L)at Visit 5

• If on vitamin D replacement or calcimimetics therapy, be at a stable dose for at leastone month prior to screening and willing to maintain the same dose throughout theduration of the study, except for safety reasons.

• Willing to maintain screening doses of lipid medication for the duration of the study,except for safety reasons.

• Willing to avoid any intentional changes in diet such as fasting or dieting.

• If female and of childbearing potential (pre-menopausal and not surgically sterile),willing to use an effective contraceptive method throughout study, which includesbarrier methods, hormones, or intrauterine devices (IUDs).

• Willing to stop all calcium supplements not prescribed by the investigator includingmultivitamins containing calcium.

• Willing to refrain from using aluminium, calcium, lanthanum, or magnesium containingantacids throughout duration of the study unless prescribed by the investigator as acalcium supplement per protocol.

• Have a level of understanding and willingness to cooperate with all visits andprocedures, including telephone contacts, as described in the consent by the studysite personnel.

Exclusion Criteria:

• Have poorly controlled diabetes mellitus or hypertension, active vasculitis, HIVinfection, or any clinically significant unstable medical condition (defined byinvestigator).

• Have active dysphagia, swallowing disorders, bowel obstruction, or severegastrointestinal motility disorders.

• Have participated in a study of an investigational drug during the 30 days precedingthe start of the screening period.

• Has active ethanol or drug dependence or abuse, excluding tobacco use.

• Have any other condition, which, in the investigator's opinion, will prohibit thepatient's participation in the study.

• If female, be pregnant or breast-feeding.

• Have any evidence of active malignancy except for basal cell carcinoma of the skin. Ahistory of malignancy is not an exclusion.

• Use of anti-arrhythmic or anti-seizure medications for arrhythmia or seizuredisorders.

• Have a known hypersensitivity to sevelamer or any of its constituents.

• Have a poor record of compliance with medication.