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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase IV, Multi-Centre, Non-interventional Study Evaluating the Effect of Lanthanum Carbonate in Patients Previously Treated With Calcium Based Phosphate Binder Therapy on Serum Phosphorous Control, Concomitant Vitamin D Therapy and Bone Related Biochemical Parameters in End Stage Renal Disease Patients on Hemodialysis

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Drug: Lanthanum carbonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients meeting all of the criteria listed below may be included in the study: Patients aged over 18 years Patients with ESRD on haemodialysis who are willing and able to provide written informed consent. 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. 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: Known or suspected intolerance or hypersensitivity to lanthanum, or any of the stated ingredients Patients with known hypophosphatemia (phosphate level below lower level of normal) Patients with severe hepatic impairment Patients with requirement for calcium supplementation for reasons other than CKD Pregnant or lactating women and women planning to become pregnant over the next 12 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lanthanum carbonate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 
| 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. | 12 months | 
| 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. | Baseline | 
| 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. | 12 months | 
| 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. | 12 months | 
| 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. | 12 months | 
| 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. | 12 months | 
| 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 | 12 months | 
| 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 Change From Baseline in iPTH Levels at 12 Months |  | Baseline and 12 months | 
| 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 | Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL | Baseline | 
| Percent of Subjects With Hypocalcemic Events on Lanthanum Carbonate | Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL | 12 months | 
| 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. | Baseline | 
| Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate | Hypercalcemia defined as total serum calcium above 11.22 mg/dL | 12 months | 
| 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 |