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

Shire66 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

End Stage Renal Disease

Interventions

Lanthanum carbonateDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (31)

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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

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

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

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.

Data from ClinicalTrials.gov

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Dialysezentrum Facharzt für Innere Medizin und Nephrologie

Homberg (Ohm), Hesse, Germany

Dialyse Alsfeld

Alsfeld, Germany

Nephrologische Praxis Altötting-Burghausen

Altötting, Germany

Dialyse am Treptower Park

Berlin, Germany

Dialyse Berlin

Berlin, Germany

Dialysezentrum Cochem

Cochem, Germany

Dialysezentrum Coesfeld

Coesfeld, Germany

MVZ Caspar-David-Friedrich-Str.

Dresden, Germany

Dialysezentrum Karlstraße

Düsseldorf, Germany

Dialysezentrum Süd

Düsseldorf, Germany

...and 21 more locations

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 12 months

Percent Change From Baseline in Phosphorous Levels at 12 Months

Time frame: Baseline and 12 months

Percent Change From Baseline in Calcium Levels at 12 Months

Time frame: Baseline and 12 months

Percent Change From Baseline in Calcium-Phosphorous Product Levels at 12 Months

Time frame: Baseline and 12 months

Percent Change From Baseline in iPTH Levels at 12 Months

Time frame: Baseline and 12 months

Percent Change From Baseline in 25-Hydroxy Vitamin D Levels at 12 Months

Time frame: Baseline and 12 months

Percent Change From Baseline in 1,25-Hydroxy Vitamin D Levels at 12 Months

Time frame: 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

Time frame: Baseline

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

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

Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate

Hypercalcemia defined as total serum calcium above 11.22 mg/dL

Time frame: 12 months

Change From Baseline in Vitamin D Dose at 12 Months

Time frame: Baseline and 12 months

Change From Baseline in Mean Total Daily Dose of Calcium at 12 Months

Time frame: Baseline and 12 months

Number of Tablets Per Day

Time frame: 12 months