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

NCT ID: NCT01130831

Last Updated: 2021-06-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-04-26
• Study Completion Date: 2012-06-12

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.

Conditions

End Stage Renal Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Lanthanum carbonate

Intervention Type: DRUG

Other Intervention Names

Fosrenol

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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

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

Hanover, , Germany

Dialysepraxen Herne und Wanne-Eickel

Herne, , Germany

Dialyse Herzberg

Herzberg, , Germany

Patienten-Heimversorgung

Hildesheim, , 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, , Germany

Countries

Germany

Other Identifiers

SPD405-702

Identifier Type: -

Identifier Source: org_study_id