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

June 4, 2021 updated by: Shire

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Calcium-based Phosphate Binder Therapy
Time Frame: 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.
Baseline
Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Lanthanum Carbonate
Time Frame: 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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent of Subjects That Achieved Controlled Serum Calcium Levels on Calcium-based Phosphate Binder Therapy
Time Frame: 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.
Baseline
Percent of Subjects That Achieved Controlled Serum Calcium Levels on Lanthanum Carbonate Therapy
Time Frame: 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.
12 months
Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Calcium-based Phosphate Binder Therapy
Time Frame: 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.
Baseline
Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy
Time Frame: 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.
12 months
Percent of Subjects That Maintained Control of Serum Phosphorous Levels on Lanthanum Carbonate
Time Frame: 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.
12 months
Percent of Subjects That Maintained Control of Serum Calcium Levels on Lanthanum Carbonate
Time Frame: 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.
12 months
Percent of Subjects That Maintained Control of Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy
Time Frame: 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.
12 months
Percent of Subjects That Maintained Control of Intact Parathyroid Hormone (iPTH) Levels on Lanthanum Carbonate Therapy
Time Frame: 12 months
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
Time Frame: Baseline and 12 months
Baseline and 12 months
Percent Change From Baseline in Calcium Levels at 12 Months
Time Frame: Baseline and 12 months
Baseline and 12 months
Percent Change From Baseline in Calcium-Phosphorous Product Levels at 12 Months
Time Frame: Baseline and 12 months
Baseline and 12 months
Percent Change From Baseline in iPTH Levels at 12 Months
Time Frame: Baseline and 12 months
Baseline and 12 months
Percent Change From Baseline in 25-Hydroxy Vitamin D Levels at 12 Months
Time Frame: Baseline and 12 months
Baseline and 12 months
Percent Change From Baseline in 1,25-Hydroxy Vitamin D Levels at 12 Months
Time Frame: Baseline and 12 months
Baseline and 12 months
Percent of Subjects With Hypocalcemic Events on Calcium-based Phosphate Binder Therapy
Time Frame: Baseline
Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL
Baseline
Percent of Subjects With Hypocalcemic Events on Lanthanum Carbonate
Time Frame: 12 months
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
Time Frame: Baseline
Hypercalcemia is defined as total serum calcium level above 11.22 mg/dL.
Baseline
Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate
Time Frame: 12 months
Hypercalcemia defined as total serum calcium above 11.22 mg/dL
12 months
Change From Baseline in Vitamin D Dose at 12 Months
Time Frame: Baseline and 12 months
Baseline and 12 months
Change From Baseline in Mean Total Daily Dose of Calcium at 12 Months
Time Frame: Baseline and 12 months
Baseline and 12 months
Number of Tablets Per Day
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 26, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 12, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 12, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPD405-702

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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