Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Following Washout 1, eligible subjects with serum phosphorus levels greater than or equal to 6.0mg/dL (greater than or equal to 1.94mmol/L) and calcium levels greater than or equal to 8.4mg/dL (greater than or equal to 2.10mmol/L) were randomized in a 1:1 ratio to receive either Fosrenol or sevelamer hydrochloride (HCl) for 4 weeks.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of the following phases: screening (1 week), washout 1 (2 weeks), treatment (4 weeks), Washout 2 (2 weeks), crossover treatment (4 weeks), and a 30-day follow-up

Reporting Groups

	Description
Fosrenol First	Fosrenol (Lanthanum carbonate) dosing began at 2250mg/day, administered orally as one 750mg tablet taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 3000mg/day, administered orally as one 1000mg tablet three times per day with meals. Subjects were to remain on the final Fosrenol dose of 3000mg/day for 3 weeks. After washout, patients then crossover to receive Sevelamer HCl for 4 weeks (see below).
Sevelamer HCl First	Sevelamer HCl dosing began at 4800mg/day, administered orally as two 800mg tablets taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 6400mg/day, administered orally as three 800mg tablets taken two times per day with meals and two 800mg tablets taken once per day with the lighter meal (i.e., a total of eight 800mg tablets per day). Subjects were to remain on the final sevelamer HCl dose of 6400mg/day for 3 weeks. After washout, patients then crossover to receive Fosrenol for 4 weeks (see above).

Participant Flow for 3 periods

	Fosrenol First	Sevelamer HCl First
STARTED	95	87
COMPLETED	77	75
NOT COMPLETED	18	12
Adverse Event	6	5
Protocol Violation	2	2
Withdrawal by Subject	3	3
Kidney transplant	1	1
Lack of Efficacy	2	0
Subject exceeded safety criteria	0	1
Subject met an exclusionary criteria	1	0
Extended hospitalization	1	0
Site error	1	0
Sponsor's request	1	0

	Fosrenol First	Sevelamer HCl First
STARTED	77	75
COMPLETED	77	75
NOT COMPLETED	0	0

	Fosrenol First	Sevelamer HCl First
STARTED	77	75
COMPLETED	65	68
NOT COMPLETED	12	7
Adverse Event	5	2
Protocol Violation	4	1
Withdrawal by Subject	1	1
Kidney Transplant	1	1
Lack of Efficacy	0	1
Subject exceeded safety criteria	1	0
Subject moved	0	1

Reporting Groups

	Description
Entire Study Population	No text entered.

Baseline Measures

	Entire Study Population
Number of Participants   [units: participants]	182
Age   [units: participants]
<=18 years	0
Between 18 and 65 years	140
>=65 years	42
Age   [units: years] Mean ± Standard Deviation	55.5 ± 13.10
Gender   [units: participants]
Female	80
Male	102
Region of Enrollment   [units: participants]
United States	139
Puerto Rico	1
Germany	41
United Kingdom	1

1.  Primary:

Change From Baseline in Serum Phosphorus Levels at 4 Weeks   [ 4 weeks ]

2.  Secondary:

Change From Baseline in Serum Calcium Levels at 4 Weeks   [ 4 weeks ]

3.  Secondary:

Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks   [ Baseline and 4 weeks ]

4.  Secondary:

Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks   [ 4 weeks ]