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End Stage Renal DiseaseNCT01130831

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

An observational study of End Stage Renal Disease, run by Shire at 31 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
End Stage Renal Disease
What is being tested?
Lanthanum carbonate
How many people
66 participants
Where
31 sitesGermany
Study dates
26 Apr 2010to 12 Jun 2012
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Haemodialysis patients with hyperphosphataemia

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

Germany31 sites

  • Dialyse Alsfeld

    Alsfeld, 36304

  • Nephrologische Praxis Altötting-Burghausen

    Altötting, 84503

  • Dialyse am Treptower Park

    Berlin, 12435

  • Dialyse Berlin

    Berlin, 12627

  • Dialysezentrum Cochem

    Cochem, 56812

  • Dialysezentrum Coesfeld

    Coesfeld, 48653

  • MVZ Caspar-David-Friedrich-Str.

    Dresden, 01217

  • Dialysezentrum Karlstraße

    Düsseldorf, 40210

  • Dialysezentrum Süd

    Düsseldorf, 40589

  • KfH-Nierenzentrum Eberswalde

    Eberswalde, 16225

  • Arzt für Dialyse, Facharzt für Innere Medizin und Nephrologie

    Essen, 45127

  • Dialysezentrum Lauerwald

    Gera, 07548

  • Dialysezentrum Grevenbroich

    Grevenbroich, 41516

  • Dialyse im Heidering

    Hanover, 30625

  • Dialysepraxen Herne und Wanne-Eickel

    Herne, 44623

  • Dialyse Herzberg

    Herzberg, 04916

  • Patienten-Heimversorgung

    Hildesheim, 31134

  • Dialysezentrum Facharzt für Innere Medizin und Nephrologie

    Homberg (Ohm), Hesse, 34576

  • Universitätsklinik des Saarlandes

    Homburg / Saar, 66421

  • Nierenzentrum Mannheim

    Mannheim, 68309

  • Dialysepraxis

    Meiningen, 98617

  • Dialyse Mettmann

    Mettmann, 40822

  • Nierenzentrum Bogenhausen

    München, 81925

  • Nephrologie Nettetal

    Nettetal, 41334

  • Dialysenzentrum Peine

    Peine, 31224

  • Facharzt für Innere Medizin und Nephrologie

    Potsdam, 14482

  • Facharzt für Innere Medizin und Nephrologie

    Quedlinburg, 6484

  • Nephrologische Praxis Schwetzingen

    Schwetzingen, 68723

  • PHV-Dialysezentrum Siegen

    Siegen, 57076

  • Nephrologisches Zentrum

    Villingen-Schwenningen

  • Dialysezentrum Worms

    Worms, 67547

Other trials in Germany

About this study

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

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.

Being tested
Lanthanum carbonate
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lanthanum carbonateDrug

    Also called Fosrenol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: 12 months

Secondary outcomes (21)

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: 12 months

  3. 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.

    Measured: Baseline

  4. 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.

    Measured: 12 months

  5. 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.

    Measured: 12 months

  6. 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.

    Measured: 12 months

  7. 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.

    Measured: 12 months

  8. 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

    Measured: 12 months

  9. Percent Change From Baseline in Phosphorous Levels at 12 Months

    Measured: Baseline and 12 months

  10. Percent Change From Baseline in Calcium Levels at 12 Months

    Measured: Baseline and 12 months

  11. Percent Change From Baseline in Calcium-Phosphorous Product Levels at 12 Months

    Measured: Baseline and 12 months

  12. Percent Change From Baseline in iPTH Levels at 12 Months

    Measured: Baseline and 12 months

  13. Percent Change From Baseline in 25-Hydroxy Vitamin D Levels at 12 Months

    Measured: Baseline and 12 months

  14. Percent Change From Baseline in 1,25-Hydroxy Vitamin D Levels at 12 Months

    Measured: Baseline and 12 months

  15. Percent of Subjects With Hypocalcemic Events on Calcium-based Phosphate Binder Therapy

    Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL

    Measured: Baseline

  16. Percent of Subjects With Hypocalcemic Events on Lanthanum Carbonate

    Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL

    Measured: 12 months

  17. 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.

    Measured: Baseline

  18. Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate

    Hypercalcemia defined as total serum calcium above 11.22 mg/dL

    Measured: 12 months

  19. Change From Baseline in Vitamin D Dose at 12 Months

    Measured: Baseline and 12 months

  20. Change From Baseline in Mean Total Daily Dose of Calcium at 12 Months

    Measured: Baseline and 12 months

  21. Number of Tablets Per Day

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2010 (estimated)
  2. Study start26 Apr 2010
  3. Primary completion12 Jun 2012
  4. Study completion12 Jun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01130831
Sponsor's protocol ID
SPD405-702
Status last verified
Jun 2021
First submitted
20 May 2010
Last updated
28 Jun 2021

Questions about this trial

What is this clinical trial studying?

An observational study of End Stage Renal Disease, run by Shire at 31 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Calcium-based Phosphate Binder Therapy (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01130831.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2021.

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