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

Completed

• Conditions: End Stage Renal Disease

• Registration Number: NCT01130831
• Lead Sponsor: Shire

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-26
• Study First Submitted: 2010-05-20
• Study First Submitted QC: 2010-05-25
• Study First Posted: 2010-05-26
• Primary Completion: 2012-06-12
• Study Completion: 2012-06-12
• Results First Submitted: 2013-04-19
• Results First Submitted QC: 2013-04-19
• Results First Posted: 2013-07-04
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-04
• Last Update Posted: 2021-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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 Phosphorous Levels at 12 Months	Baseline and 12 months
Percent Change From Baseline in iPTH Levels at 12 Months	Baseline and 12 months
Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate	12 months	Hypercalcemia defined as total serum calcium above 11.22 mg/dL
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.
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 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 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 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 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 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
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
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 1,25-Hydroxy Vitamin D Levels at 12 Months	Baseline and 12 months
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.
Number of Tablets Per Day	12 months

Trial Locations

Locations (30)

Dialyse am Treptower Park; 🇩🇪 Berlin, Germany

Dialyse Alsfeld; 🇩🇪 Alsfeld, Germany

Nephrologische Praxis Altötting-Burghausen; 🇩🇪 Altötting, Germany

Dialysezentrum Cochem; 🇩🇪 Cochem, Germany

Dialyse Berlin; 🇩🇪 Berlin, Germany

Dialysezentrum Coesfeld; 🇩🇪 Coesfeld, Germany

Dialysezentrum Karlstraße; 🇩🇪 Düsseldorf, Germany

MVZ Caspar-David-Friedrich-Str.; 🇩🇪 Dresden, Germany

Dialysezentrum Süd; 🇩🇪 Düsseldorf, Germany

Dialysezentrum Grevenbroich; 🇩🇪 Grevenbroich, Germany

Dialysezentrum Lauerwald; 🇩🇪 Gera, Germany

Dialyse im Heidering; 🇩🇪 Hannover, Germany

KfH-Nierenzentrum Eberswalde; 🇩🇪 Eberswalde, Germany

Arzt für Dialyse, Facharzt für Innere Medizin und Nephrologie; 🇩🇪 Essen, Germany

Dialysepraxis; 🇩🇪 Meiningen, Germany

Dialysepraxen Herne und Wanne-Eickel; 🇩🇪 Herne, Germany

Universitätsklinik des Saarlandes; 🇩🇪 Homburg / Saar, Germany

Patienten-Heimversorgung; 🇩🇪 Hildesheim, Germany

Dialyse Mettmann; 🇩🇪 Mettmann, Germany

Dialyse Herzberg; 🇩🇪 Herzberg, Germany

Nierenzentrum Mannheim; 🇩🇪 Mannheim, Germany

PHV-Dialysezentrum Siegen; 🇩🇪 Siegen, Germany

Dialysenzentrum Peine; 🇩🇪 Peine, Germany

Nephrologie Nettetal; 🇩🇪 Nettetal, Germany

Nephrologische Praxis Schwetzingen; 🇩🇪 Schwetzingen, Germany

Nierenzentrum Bogenhausen; 🇩🇪 München, Germany

Facharzt für Innere Medizin und Nephrologie; 🇩🇪 Quedlinburg, Germany

Dialysezentrum Worms; 🇩🇪 Worms, Germany

Nephrologisches Zentrum; 🇩🇪 Villingen Schwenningen, Germany

Dialysezentrum Facharzt für Innere Medizin und Nephrologie; 🇩🇪 Homberg, Hesse, Germany