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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130831
• Other study ID #: SPD405-702
• Status: Completed
• Start date: April 26, 2010
• Est. completion date: June 12, 2012

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 12, 2012
• Est. primary completion date: June 12, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Drug:
• Lanthanum carbonate

Locations

Country	Name	City	State
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	KfH-Nierenzentrum Eberswalde	Eberswalde
Germany	Arzt für Dialyse, Facharzt für Innere Medizin und Nephrologie	Essen
Germany	Dialysezentrum Lauerwald	Gera
Germany	Dialysezentrum Grevenbroich	Grevenbroich
Germany	Dialyse im Heidering	Hannover
Germany	Dialysepraxen Herne und Wanne-Eickel	Herne
Germany	Dialyse Herzberg	Herzberg
Germany	Patienten-Heimversorgung	Hildesheim
Germany	Dialysezentrum Facharzt für Innere Medizin und Nephrologie	Homberg	Hesse
Germany	Universitätsklinik des Saarlandes	Homburg / Saar
Germany	Nierenzentrum Mannheim	Mannheim
Germany	Dialysepraxis	Meiningen
Germany	Dialyse Mettmann	Mettmann
Germany	Nierenzentrum Bogenhausen	München
Germany	Nephrologie Nettetal	Nettetal
Germany	Dialysenzentrum Peine	Peine
Germany	Facharzt für Innere Medizin und Nephrologie	Potsdam
Germany	Facharzt für Innere Medizin und Nephrologie	Quedlinburg
Germany	Nephrologische Praxis Schwetzingen	Schwetzingen
Germany	PHV-Dialysezentrum Siegen	Siegen
Germany	Nephrologisches Zentrum	Villingen Schwenningen
Germany	Dialysezentrum Worms	Worms

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline
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.	12 months
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.	Baseline
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.	12 months
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.	Baseline
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.	12 months
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.	12 months
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.	12 months
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.	12 months
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	12 months
Secondary	Percent Change From Baseline in Phosphorous Levels at 12 Months		Baseline and 12 months
Secondary	Percent Change From Baseline in Calcium Levels at 12 Months		Baseline and 12 months
Secondary	Percent Change From Baseline in Calcium-Phosphorous Product Levels at 12 Months		Baseline and 12 months
Secondary	Percent Change From Baseline in iPTH Levels at 12 Months		Baseline and 12 months
Secondary	Percent Change From Baseline in 25-Hydroxy Vitamin D Levels at 12 Months		Baseline and 12 months
Secondary	Percent Change From Baseline in 1,25-Hydroxy Vitamin D Levels at 12 Months		Baseline and 12 months
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	Baseline
Secondary	Percent of Subjects With Hypocalcemic Events on Lanthanum Carbonate	Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL	12 months
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.	Baseline
Secondary	Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate	Hypercalcemia defined as total serum calcium above 11.22 mg/dL	12 months
Secondary	Change From Baseline in Vitamin D Dose at 12 Months		Baseline and 12 months
Secondary	Change From Baseline in Mean Total Daily Dose of Calcium at 12 Months		Baseline and 12 months
Secondary	Number of Tablets Per Day		12 months