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

NCT01130831 | Completed Results

• 1 other identifier: SPD405-702
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 31

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (21)

• Percent of Subjects That Achieved Controlled Serum Calcium Levels on Calcium-based Phosphate Binder Therapy

  Baseline

• Percent of Subjects That Achieved Controlled Serum Calcium Levels on Lanthanum Carbonate Therapy

  12 months

• Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Calcium-based Phosphate Binder Therapy

  Baseline

• Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy

  12 months

• Percent of Subjects That Maintained Control of Serum Phosphorous Levels on Lanthanum Carbonate

  12 months

Interventions

Lanthanum carbonate DRUG

Also known as: Fosrenol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Haemodialysis patients with hyperphosphataemia

You may qualify if:

• Patients meeting all of the criteria listed below may be included in the study:
• Patients aged over 18 years
• Patients with ESRD on haemodialysis who are willing and able to provide written informed consent.
• 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.
• 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.

You may not qualify if:

• Patients are excluded from the study if any of the following criteria are met at screening:
• Known or suspected intolerance or hypersensitivity to lanthanum, or any of the stated ingredients
• Patients with known hypophosphatemia (phosphate level below lower level of normal)
• Patients with severe hepatic impairment
• Patients with requirement for calcium supplementation for reasons other than CKD
• Pregnant or lactating women and women planning to become pregnant over the next 12 months

Sponsors & Collaborators

• Shire: lead

Study Sites (31)

Dialysezentrum Facharzt für Innere Medizin und Nephrologie

Homberg (Ohm), Hesse, 34576, Germany

Location

Dialyse Alsfeld

Alsfeld, 36304, Germany

Location

Nephrologische Praxis Altötting-Burghausen

Altötting, 84503, Germany

Location

Dialyse am Treptower Park

Berlin, 12435, Germany

Location

Dialyse Berlin

Berlin, 12627, Germany

Location

Dialysezentrum Cochem

Cochem, 56812, Germany

Location

Dialysezentrum Coesfeld

Coesfeld, 48653, Germany

Location

MVZ Caspar-David-Friedrich-Str.

Dresden, 01217, Germany

Location

Dialysezentrum Karlstraße

Düsseldorf, 40210, Germany

Location

Dialysezentrum Süd

Düsseldorf, 40589, Germany

Location

KfH-Nierenzentrum Eberswalde

Eberswalde, 16225, Germany

Location

Arzt für Dialyse, Facharzt für Innere Medizin und Nephrologie

Essen, 45127, Germany

Location

Dialysezentrum Lauerwald

Gera, 07548, Germany

Location

Dialysezentrum Grevenbroich

Grevenbroich, 41516, Germany

Location

Dialyse im Heidering

Hanover, 30625, Germany

Location

Dialysepraxen Herne und Wanne-Eickel

Herne, 44623, Germany

Location

Dialyse Herzberg

Herzberg, 04916, Germany

Location

Patienten-Heimversorgung

Hildesheim, 31134, Germany

Location

Universitätsklinik des Saarlandes

Homburg / Saar, 66421, Germany

Location

Nierenzentrum Mannheim

Mannheim, 68309, Germany

Location

Dialysepraxis

Meiningen, 98617, Germany

Location

Dialyse Mettmann

Mettmann, 40822, Germany

Location

Nierenzentrum Bogenhausen

München, 81925, Germany

Location

Nephrologie Nettetal

Nettetal, 41334, Germany

Location

Dialysenzentrum Peine

Peine, 31224, Germany

Location

Facharzt für Innere Medizin und Nephrologie

Potsdam, 14482, Germany

Location

Facharzt für Innere Medizin und Nephrologie

Quedlinburg, 6484, Germany

Location

Nephrologische Praxis Schwetzingen

Schwetzingen, 68723, Germany

Location

PHV-Dialysezentrum Siegen

Siegen, 57076, Germany

Location

Nephrologisches Zentrum

Villingen-Schwenningen, Germany

Location

Dialysezentrum Worms

Worms, 67547, Germany

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

lanthanum carbonate

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 26, 2010
• Study Start: April 26, 2010
• Primary Completion: June 12, 2012
• Study Completion: June 12, 2012
• Last Updated: June 28, 2021
• Results First Posted: July 4, 2013

Record last verified: 2021-06

Locations

DE (31)