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

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

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 Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Drug: Lanthanum carbonate

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• Germany
  • Alsfeld, Germany, 36304
    • Dialyse Alsfeld
  • Altötting, Germany, 84503
    • Nephrologische Praxis Altötting-Burghausen
  • Berlin, Germany, 12435
    • Dialyse am Treptower Park
  • Berlin, Germany, 12627
    • Dialyse Berlin
  • Cochem, Germany, 56812
    • Dialysezentrum Cochem
  • Coesfeld, Germany, 48653
    • Dialysezentrum Coesfeld
  • Dresden, Germany, 01217
    • MVZ Caspar-David-Friedrich-Str.
  • Düsseldorf, Germany, 40210
    • Dialysezentrum Karlstraße
  • Düsseldorf, Germany, 40589
    • Dialysezentrum Süd
  • Eberswalde, Germany, 16225
    • KfH-Nierenzentrum Eberswalde
  • Essen, Germany, 45127
    • Arzt für Dialyse, Facharzt für Innere Medizin und Nephrologie
  • Gera, Germany, 07548
    • Dialysezentrum Lauerwald
  • Grevenbroich, Germany, 41516
    • Dialysezentrum Grevenbroich
  • Hannover, Germany, 30625
    • Dialyse im Heidering
  • Herne, Germany, 44623
    • Dialysepraxen Herne und Wanne-Eickel
  • Herzberg, Germany, 04916
    • Dialyse Herzberg
  • Hildesheim, Germany, 31134
    • Patienten-Heimversorgung
  • Homburg / Saar, Germany, 66421
    • Universitätsklinik des Saarlandes
  • Mannheim, Germany, 68309
    • Nierenzentrum Mannheim
  • Meiningen, Germany, 98617
    • Dialysepraxis
  • Mettmann, Germany, 40822
    • Dialyse Mettmann
  • München, Germany, 81925
    • Nierenzentrum Bogenhausen
  • Nettetal, Germany, 41334
    • Nephrologie Nettetal
  • Peine, Germany, 31224
    • Dialysenzentrum Peine
  • Potsdam, Germany, 14482
    • Facharzt für Innere Medizin und Nephrologie
  • Quedlinburg, Germany, 6484
    • Facharzt für Innere Medizin und Nephrologie
  • Schwetzingen, Germany, 68723
    • Nephrologische Praxis Schwetzingen
  • Siegen, Germany, 57076
    • PHV-Dialysezentrum Siegen
  • Villingen Schwenningen, Germany
    • Nephrologisches Zentrum
  • Worms, Germany, 67547
    • Dialysezentrum Worms
  • Hesse
    • Homberg, Hesse, Germany, 34576
      • Dialysezentrum Facharzt für Innere Medizin und Nephrologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Haemodialysis patients with hyperphosphataemia

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shire

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2010
• Primary Completion (Actual): June 12, 2012
• Study Completion (Actual): June 12, 2012

Study Registration Dates

• First Submitted: May 20, 2010
• First Submitted That Met QC Criteria: May 25, 2010
• First Posted (Estimate): May 26, 2010

Study Record Updates

• Last Update Posted (Actual): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: SPD405-702