Effect of Lanthanum Carbonate in Patients Previously Treated With Calcium-based Phosphate Binder Therapy

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Lanthanum Carbonate	Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.

Participant Flow:   Overall Study

	Lanthanum Carbonate
STARTED	66
COMPLETED	52
NOT COMPLETED	14
Withdrawal by Subject	7
Death	4
Information was missing	3

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Analysis Set included all screened subjects who took at least 1 dose of lanthanum carbonate and for whom 1 follow-up assessment was completed (n = 61).

Reporting Groups

	Description
Lanthanum Carbonate	Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.

Baseline Measures

	Lanthanum Carbonate
Overall Participants Analyzed  [Units: Participants]	61
Age  [Units: Years] Mean (Standard Deviation)	66.0  (12.5)
Age, Customized  [Units: Participants]
>=18 years	61
Gender  [Units: Participants]
Female	22
Male	39
Region of Enrollment [1]  [Units: Participants]
Germany	66
[1] All screened subjects

1.  Primary:

Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Calcium-based Phosphate Binder Therapy   [ Time Frame: Baseline ]

2.  Primary:

Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Lanthanum Carbonate   [ Time Frame: 12 months ]

3.  Secondary:

Percent of Subjects That Achieved Controlled Serum Calcium Levels on Calcium-based Phosphate Binder Therapy   [ Time Frame: Baseline ]

4.  Secondary:

Percent of Subjects That Achieved Controlled Serum Calcium Levels on Lanthanum Carbonate Therapy   [ Time Frame: 12 months ]

5.  Secondary:

Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Calcium-based Phosphate Binder Therapy   [ Time Frame: Baseline ]

6.  Secondary:

Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy   [ Time Frame: 12 months ]

7.  Secondary:

Percent of Subjects That Maintained Control of Serum Phosphorous Levels on Lanthanum Carbonate   [ Time Frame: 12 months ]

8.  Secondary:

Percent of Subjects That Maintained Control of Serum Calcium Levels on Lanthanum Carbonate   [ Time Frame: 12 months ]

9.  Secondary:

Percent of Subjects That Maintained Control of Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy   [ Time Frame: 12 months ]

10.  Secondary:

Percent of Subjects That Maintained Control of Intact Parathyroid Hormone (iPTH) Levels on Lanthanum Carbonate Therapy   [ Time Frame: 12 months ]

11.  Secondary:

Percent Change From Baseline in Phosphorous Levels at 12 Months   [ Time Frame: Baseline and 12 months ]

12.  Secondary:

Percent Change From Baseline in Calcium Levels at 12 Months   [ Time Frame: Baseline and 12 months ]

13.  Secondary:

Percent Change From Baseline in Calcium-Phosphorous Product Levels at 12 Months   [ Time Frame: Baseline and 12 months ]

14.  Secondary:

Percent Change From Baseline in iPTH Levels at 12 Months   [ Time Frame: Baseline and 12 months ]

15.  Secondary:

Percent Change From Baseline in 25-Hydroxy Vitamin D Levels at 12 Months   [ Time Frame: Baseline and 12 months ]

16.  Secondary:

Percent Change From Baseline in 1,25-Hydroxy Vitamin D Levels at 12 Months   [ Time Frame: Baseline and 12 months ]

17.  Secondary:

Percent of Subjects With Hypocalcemic Events on Calcium-based Phosphate Binder Therapy   [ Time Frame: Baseline ]

18.  Secondary:

Percent of Subjects With Hypocalcemic Events on Lanthanum Carbonate   [ Time Frame: 12 months ]

19.  Secondary:

Percent of Subjects With Hypercalcemic Events on Calcium-based Phosphate Binder Therapy   [ Time Frame: Baseline ]

20.  Secondary:

Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate   [ Time Frame: 12 months ]

21.  Secondary:

Change From Baseline in Vitamin D Dose at 12 Months   [ Time Frame: Baseline and 12 months ]

22.  Secondary:

Change From Baseline in Mean Total Daily Dose of Calcium at 12 Months   [ Time Frame: Baseline and 12 months ]

23.  Secondary:

Number of Tablets Per Day   [ Time Frame: 12 months ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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