End Stage Renal Disease
Conditions
Brief summary
To assess the percentage of patients on lanthanum carbonate, that achieve Kidney Disease Outcome Quality Initiative (KDOQI) guideline suggested values for serum phosphorous in patients previously treated with calcium-based phosphate binder therapy.
Interventions
DRUGLanthanum carbonate
Sponsors
Shire
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients meeting all of the criteria listed below may be included in the study: 1. Patients aged over 18 years 2. Patients with ESRD on haemodialysis who are willing and able to provide written informed consent. 3. Patients on: * Lanthanum carbonate monotherapy for ≥1 month * Lanthanum carbonate monotherapy for ≤3 months * Calcium-based monotherapy for ≥3 months immediately prior to lanthanum carbonate therapy. 4. Values recorded in medical records detailing serum phosphorous, serum calcium-phosphorus product, iPTH, and medication ≤6 months prior to commencing lanthanum carbonate therapy and whilst on a calcium-based monotherapy.
Exclusion criteria
Patients are excluded from the study if any of the following criteria are met at screening: 1. Known or suspected intolerance or hypersensitivity to lanthanum, or any of the stated ingredients 2. Patients with known hypophosphatemia (phosphate level below lower level of normal) 3. Patients with severe hepatic impairment 4. Patients with requirement for calcium supplementation for reasons other than CKD 5. Pregnant or lactating women and women planning to become pregnant over the next 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Calcium-based Phosphate Binder Therapy | Baseline | Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL. |
| Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Lanthanum Carbonate | 12 months | Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Calcium-based Phosphate Binder Therapy | Baseline | Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of \<55 mg\^2/dL\^2. |
| Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy | 12 months | Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of \<55 mg\^2/dL\^2. |
| Percent of Subjects That Maintained Control of Serum Phosphorous Levels on Lanthanum Carbonate | 12 months | Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL. |
| Percent of Subjects That Maintained Control of Serum Calcium Levels on Lanthanum Carbonate | 12 months | Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL. |
| Percent of Subjects That Maintained Control of Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy | 12 months | Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of \<55 mg\^2/dL\^2. |
| Percent of Subjects That Maintained Control of Intact Parathyroid Hormone (iPTH) Levels on Lanthanum Carbonate Therapy | 12 months | iPTH levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for iPTH of 150-300 pg/mL |
| Percent Change From Baseline in Phosphorous Levels at 12 Months | Baseline and 12 months | — |
| Percent Change From Baseline in Calcium Levels at 12 Months | Baseline and 12 months | — |
| Percent Change From Baseline in Calcium-Phosphorous Product Levels at 12 Months | Baseline and 12 months | — |
| Percent of Subjects That Achieved Controlled Serum Calcium Levels on Calcium-based Phosphate Binder Therapy | Baseline | Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL. |
| Percent Change From Baseline in 25-Hydroxy Vitamin D Levels at 12 Months | Baseline and 12 months | — |
| Percent Change From Baseline in 1,25-Hydroxy Vitamin D Levels at 12 Months | Baseline and 12 months | — |
| Percent of Subjects With Hypocalcemic Events on Calcium-based Phosphate Binder Therapy | Baseline | Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL |
| Percent of Subjects With Hypocalcemic Events on Lanthanum Carbonate | 12 months | Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL |
| Percent of Subjects With Hypercalcemic Events on Calcium-based Phosphate Binder Therapy | Baseline | Hypercalcemia is defined as total serum calcium level above 11.22 mg/dL. |
| Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate | 12 months | Hypercalcemia defined as total serum calcium above 11.22 mg/dL |
| Change From Baseline in Vitamin D Dose at 12 Months | Baseline and 12 months | — |
| Change From Baseline in Mean Total Daily Dose of Calcium at 12 Months | Baseline and 12 months | — |
| Number of Tablets Per Day | 12 months | — |
| Percent Change From Baseline in iPTH Levels at 12 Months | Baseline and 12 months | — |
| Percent of Subjects That Achieved Controlled Serum Calcium Levels on Lanthanum Carbonate Therapy | 12 months | Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lanthanum Carbonate Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for \>=3 months. | 61 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 4 |
| Overall Study | Information was missing | 3 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Lanthanum Carbonate |
|---|---|
| Age, Continuous | 66.0 years STANDARD_DEVIATION 12.5 |
| Age, Customized >=18 years | 61 Participants |
| Region of Enrollment Germany | 61 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 61 |
| serious Total, serious adverse events | 0 / 61 |
Outcome results
Primary
Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Calcium-based Phosphate Binder Therapy
Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.
Time frame: Baseline
Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calcium-based Phosphate Binder Therapy | Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Calcium-based Phosphate Binder Therapy | 14.9 percentage of subjects |
Primary
Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Lanthanum Carbonate
Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.
Time frame: 12 months
Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calcium-based Phosphate Binder Therapy | Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Lanthanum Carbonate | 40.0 percentage of subjects |
Secondary
Change From Baseline in Mean Total Daily Dose of Calcium at 12 Months
Time frame: Baseline and 12 months
Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcium-based Phosphate Binder Therapy | Change From Baseline in Mean Total Daily Dose of Calcium at 12 Months | -178.6 mg | Standard Deviation 437.6 |
Secondary
Change From Baseline in Vitamin D Dose at 12 Months
Time frame: Baseline and 12 months
Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcium-based Phosphate Binder Therapy | Change From Baseline in Vitamin D Dose at 12 Months | -0.7 ng | Standard Deviation 0.0075 |
Secondary
Number of Tablets Per Day
Time frame: 12 months
Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcium-based Phosphate Binder Therapy | Number of Tablets Per Day | 3.4 Number of Tablets | Standard Deviation 1.3 |
Secondary
Percent Change From Baseline in 1,25-Hydroxy Vitamin D Levels at 12 Months
Time frame: Baseline and 12 months
Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy. Note that there are a high number of missing values (n=38) for this outcome which does not allow for any meaningful comparison.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcium-based Phosphate Binder Therapy | Percent Change From Baseline in 1,25-Hydroxy Vitamin D Levels at 12 Months | 1.1 percent change in vitamin D | Standard Deviation 28.6 |
Secondary
Percent Change From Baseline in 25-Hydroxy Vitamin D Levels at 12 Months
Time frame: Baseline and 12 months
Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy. Note that there are a high number of missing values (n=36) for this outcome which does not allow for any meaningful comparison.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcium-based Phosphate Binder Therapy | Percent Change From Baseline in 25-Hydroxy Vitamin D Levels at 12 Months | 41.0 percent change in vitamin D | Standard Deviation 48.6 |
Secondary
Percent Change From Baseline in Calcium Levels at 12 Months
Time frame: Baseline and 12 months
Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcium-based Phosphate Binder Therapy | Percent Change From Baseline in Calcium Levels at 12 Months | -1.1 percent change in calcium levels | Standard Deviation 8.1 |
Secondary
Percent Change From Baseline in Calcium-Phosphorous Product Levels at 12 Months
Time frame: Baseline and 12 months
Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcium-based Phosphate Binder Therapy | Percent Change From Baseline in Calcium-Phosphorous Product Levels at 12 Months | -8.7 percent change in calcium-phosphorous | Standard Deviation 26.5 |
Secondary
Percent Change From Baseline in iPTH Levels at 12 Months
Time frame: Baseline and 12 months
Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcium-based Phosphate Binder Therapy | Percent Change From Baseline in iPTH Levels at 12 Months | 95.4 percent change in iPTH levels | Standard Deviation 393.4 |
Secondary
Percent Change From Baseline in Phosphorous Levels at 12 Months
Time frame: Baseline and 12 months
Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcium-based Phosphate Binder Therapy | Percent Change From Baseline in Phosphorous Levels at 12 Months | -7.9 percent change in phosphorous levels | Standard Deviation 24.3 |
Secondary
Percent of Subjects That Achieved Controlled Serum Calcium Levels on Calcium-based Phosphate Binder Therapy
Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL.
Time frame: Baseline
Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calcium-based Phosphate Binder Therapy | Percent of Subjects That Achieved Controlled Serum Calcium Levels on Calcium-based Phosphate Binder Therapy | 68.1 percentage of subjects |
Secondary
Percent of Subjects That Achieved Controlled Serum Calcium Levels on Lanthanum Carbonate Therapy
Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL.
Time frame: 12 months
Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calcium-based Phosphate Binder Therapy | Percent of Subjects That Achieved Controlled Serum Calcium Levels on Lanthanum Carbonate Therapy | 52.5 percentage of subjects |
Secondary
Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Calcium-based Phosphate Binder Therapy
Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of \<55 mg\^2/dL\^2.
Time frame: Baseline
Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calcium-based Phosphate Binder Therapy | Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Calcium-based Phosphate Binder Therapy | 42.6 percentage of subjects |
Secondary
Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy
Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of \<55 mg\^2/dL\^2.
Time frame: 12 months
Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calcium-based Phosphate Binder Therapy | Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy | 75.0 percentage of subjects |
Secondary
Percent of Subjects That Maintained Control of Intact Parathyroid Hormone (iPTH) Levels on Lanthanum Carbonate Therapy
iPTH levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for iPTH of 150-300 pg/mL
Time frame: 12 months
Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Calcium-based Phosphate Binder Therapy | Percent of Subjects That Maintained Control of Intact Parathyroid Hormone (iPTH) Levels on Lanthanum Carbonate Therapy | <=1 quarter | 81.6 percentage of subjects |
| Calcium-based Phosphate Binder Therapy | Percent of Subjects That Maintained Control of Intact Parathyroid Hormone (iPTH) Levels on Lanthanum Carbonate Therapy | 2 consecutive quarters | 10.5 percentage of subjects |
| Calcium-based Phosphate Binder Therapy | Percent of Subjects That Maintained Control of Intact Parathyroid Hormone (iPTH) Levels on Lanthanum Carbonate Therapy | 3 consecutive quarters | 2.6 percentage of subjects |
| Calcium-based Phosphate Binder Therapy | Percent of Subjects That Maintained Control of Intact Parathyroid Hormone (iPTH) Levels on Lanthanum Carbonate Therapy | 4 consecutive quarters | 5.3 percentage of subjects |
Secondary
Percent of Subjects That Maintained Control of Serum Calcium Levels on Lanthanum Carbonate
Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL.
Time frame: 12 months
Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Calcium-based Phosphate Binder Therapy | Percent of Subjects That Maintained Control of Serum Calcium Levels on Lanthanum Carbonate | <=1 quarter | 53.7 percentage of subjects |
| Calcium-based Phosphate Binder Therapy | Percent of Subjects That Maintained Control of Serum Calcium Levels on Lanthanum Carbonate | 2 consecutive quarters | 22.0 percentage of subjects |
| Calcium-based Phosphate Binder Therapy | Percent of Subjects That Maintained Control of Serum Calcium Levels on Lanthanum Carbonate | 3 consecutive quarters | 7.3 percentage of subjects |
| Calcium-based Phosphate Binder Therapy | Percent of Subjects That Maintained Control of Serum Calcium Levels on Lanthanum Carbonate | 4 consecutive quarters | 17.1 percentage of subjects |
Secondary
Percent of Subjects That Maintained Control of Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy
Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of \<55 mg\^2/dL\^2.
Time frame: 12 months
Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Calcium-based Phosphate Binder Therapy | Percent of Subjects That Maintained Control of Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy | <=1 quarter | 47.5 percentage of subjects |
| Calcium-based Phosphate Binder Therapy | Percent of Subjects That Maintained Control of Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy | 2 consecutive quarters | 17.5 percentage of subjects |
| Calcium-based Phosphate Binder Therapy | Percent of Subjects That Maintained Control of Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy | 3 consecutive quarters | 5.0 percentage of subjects |
| Calcium-based Phosphate Binder Therapy | Percent of Subjects That Maintained Control of Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy | 4 consecutive quarters | 30.0 percentage of subjects |
Secondary
Percent of Subjects That Maintained Control of Serum Phosphorous Levels on Lanthanum Carbonate
Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.
Time frame: 12 months
Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Calcium-based Phosphate Binder Therapy | Percent of Subjects That Maintained Control of Serum Phosphorous Levels on Lanthanum Carbonate | <=1 quarter | 73.8 percentage of subjects |
| Calcium-based Phosphate Binder Therapy | Percent of Subjects That Maintained Control of Serum Phosphorous Levels on Lanthanum Carbonate | 2 consecutive quarters | 7.1 percentage of subjects |
| Calcium-based Phosphate Binder Therapy | Percent of Subjects That Maintained Control of Serum Phosphorous Levels on Lanthanum Carbonate | 3 consecutive quarters | 7.1 percentage of subjects |
| Calcium-based Phosphate Binder Therapy | Percent of Subjects That Maintained Control of Serum Phosphorous Levels on Lanthanum Carbonate | 4 consecutive quarters | 11.9 percentage of subjects |
Secondary
Percent of Subjects With Hypercalcemic Events on Calcium-based Phosphate Binder Therapy
Hypercalcemia is defined as total serum calcium level above 11.22 mg/dL.
Time frame: Baseline
Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calcium-based Phosphate Binder Therapy | Percent of Subjects With Hypercalcemic Events on Calcium-based Phosphate Binder Therapy | 0.0 percentage of subjects |
Secondary
Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate
Hypercalcemia defined as total serum calcium above 11.22 mg/dL
Time frame: 12 months
Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calcium-based Phosphate Binder Therapy | Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate | 0.0 percentage of subjects |
Secondary
Percent of Subjects With Hypocalcemic Events on Calcium-based Phosphate Binder Therapy
Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL
Time frame: Baseline
Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calcium-based Phosphate Binder Therapy | Percent of Subjects With Hypocalcemic Events on Calcium-based Phosphate Binder Therapy | 10.6 percentage of subjects |
Secondary
Percent of Subjects With Hypocalcemic Events on Lanthanum Carbonate
Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL
Time frame: 12 months
Population: Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calcium-based Phosphate Binder Therapy | Percent of Subjects With Hypocalcemic Events on Lanthanum Carbonate | 22.5 percentage of subjects |