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CompletedNCT01130831Updated Jun 28, 2021Results posted

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

An observational study in End Stage Renal Disease, sponsored by Shire. Completed at 31 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-28.

Sponsored by Shire · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
66
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • End Stage Renal Disease
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 66 is below the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 47 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Haemodialysis patients with hyperphosphataemia

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
66 participants (actual)

Interventions

  • DrugLanthanum carbonate

    Also known as: Fosrenol

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 12 months

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 12 months

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

    Time frame: Baseline and 12 months

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

    Time frame: Baseline and 12 months

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

    Time frame: Baseline and 12 months

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

    Time frame: Baseline and 12 months

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

    Time frame: Baseline and 12 months

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

    Time frame: 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

    Time frame: Baseline

  16. Percent of Subjects With Hypocalcemic Events on Lanthanum Carbonate

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

    Time frame: 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.

    Time frame: Baseline

  18. Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate

    Hypercalcemia defined as total serum calcium above 11.22 mg/dL

    Time frame: 12 months

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

    Time frame: Baseline and 12 months

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

    Time frame: Baseline and 12 months

  21. Number of Tablets Per Day

    Time frame: 12 months

07

Results

Posted Jul 4, 2013

Participant flow

Participant flow — Overall Study
MilestoneLanthanum Carbonate
Started66
Completed52
Not completed14
Withdrew: Withdrawal by subject7
Withdrew: Death4
Withdrew: Information was missing3

Outcome measures

PrimaryPercent 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.

Time frame:
Baseline
Reported as:
Number · percentage of subjects
Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Calcium-based Phosphate Binder Therapy
percentage of subjectsCalcium-based Phosphate Binder Therapy
Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Calcium-based Phosphate Binder Therapy14.9 (6.2 to 28.3)
SecondaryPercent 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.

Time frame:
Baseline
Reported as:
Number · percentage of subjects
Percent of Subjects That Achieved Controlled Serum Calcium Levels on Calcium-based Phosphate Binder Therapy
percentage of subjectsCalcium-based Phosphate Binder Therapy
Percent of Subjects That Achieved Controlled Serum Calcium Levels on Calcium-based Phosphate Binder Therapy68.1 (52.9 to 80.9)
SecondaryPercent 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.

Time frame:
12 months
Reported as:
Number · percentage of subjects
Percent of Subjects That Achieved Controlled Serum Calcium Levels on Lanthanum Carbonate Therapy
percentage of subjectsLanthanum Carbonate
Percent of Subjects That Achieved Controlled Serum Calcium Levels on Lanthanum Carbonate Therapy52.5 (36.1 to 68.5)
SecondaryPercent 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.

Time frame:
Baseline
Reported as:
Number · percentage of subjects
Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Calcium-based Phosphate Binder Therapy
percentage of subjectsCalcium-based Phosphate Binder Therapy
Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Calcium-based Phosphate Binder Therapy42.6 (28.3 to 57.8)
SecondaryPercent 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.

Time frame:
12 months
Reported as:
Number · percentage of subjects
Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy
percentage of subjectsLanthanum Carbonate
Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy75.0 (58.8 to 87.3)
SecondaryPercent 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.

Time frame:
12 months
Reported as:
Number · percentage of subjects
Percent of Subjects That Maintained Control of Serum Phosphorous Levels on Lanthanum Carbonate
percentage of subjectsLanthanum Carbonate
<=1 quarter73.8
2 consecutive quarters7.1
3 consecutive quarters7.1
4 consecutive quarters11.9
SecondaryPercent 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.

Time frame:
12 months
Reported as:
Number · percentage of subjects
Percent of Subjects That Maintained Control of Serum Calcium Levels on Lanthanum Carbonate
percentage of subjectsLanthanum Carbonate
<=1 quarter53.7
2 consecutive quarters22.0
3 consecutive quarters7.3
4 consecutive quarters17.1
SecondaryPercent 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.

Time frame:
12 months
Reported as:
Number · percentage of subjects
Percent of Subjects That Maintained Control of Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy
percentage of subjectsLanthanum Carbonate
<=1 quarter47.5
2 consecutive quarters17.5
3 consecutive quarters5.0
4 consecutive quarters30.0
PrimaryPercent 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.

Time frame:
12 months
Reported as:
Number · percentage of subjects
Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Lanthanum Carbonate
percentage of subjectsLanthanum Carbonate
Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Lanthanum Carbonate40.0 (24.9 to 56.7)
SecondaryPercent 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

Time frame:
12 months
Reported as:
Number · percentage of subjects
Percent of Subjects That Maintained Control of Intact Parathyroid Hormone (iPTH) Levels on Lanthanum Carbonate Therapy
percentage of subjectsLanthanum Carbonate
<=1 quarter81.6
2 consecutive quarters10.5
3 consecutive quarters2.6
4 consecutive quarters5.3
SecondaryPercent Change From Baseline in Phosphorous Levels at 12 Months
Time frame:
Baseline and 12 months
Reported as:
Mean · percent change in phosphorous levels
Percent Change From Baseline in Phosphorous Levels at 12 Months
percent change in phosphorous levelsLanthanum Carbonate
Percent Change From Baseline in Phosphorous Levels at 12 Months-7.9 ± 24.3
SecondaryPercent Change From Baseline in Calcium Levels at 12 Months
Time frame:
Baseline and 12 months
Reported as:
Mean · percent change in calcium levels
Percent Change From Baseline in Calcium Levels at 12 Months
percent change in calcium levelsLanthanum Carbonate
Percent Change From Baseline in Calcium Levels at 12 Months-1.1 ± 8.1
SecondaryPercent Change From Baseline in Calcium-Phosphorous Product Levels at 12 Months
Time frame:
Baseline and 12 months
Reported as:
Mean · percent change in calcium-phosphorous
Percent Change From Baseline in Calcium-Phosphorous Product Levels at 12 Months
percent change in calcium-phosphorousLanthanum Carbonate
Percent Change From Baseline in Calcium-Phosphorous Product Levels at 12 Months-8.7 ± 26.5
SecondaryPercent Change From Baseline in iPTH Levels at 12 Months
Time frame:
Baseline and 12 months
Reported as:
Mean · percent change in iPTH levels
Percent Change From Baseline in iPTH Levels at 12 Months
percent change in iPTH levelsLanthanum Carbonate
Percent Change From Baseline in iPTH Levels at 12 Months95.4 ± 393.4
SecondaryPercent Change From Baseline in 25-Hydroxy Vitamin D Levels at 12 Months
Time frame:
Baseline and 12 months
Reported as:
Mean · percent change in vitamin D
Percent Change From Baseline in 25-Hydroxy Vitamin D Levels at 12 Months
percent change in vitamin DLanthanum Carbonate
Percent Change From Baseline in 25-Hydroxy Vitamin D Levels at 12 Months41.0 ± 48.6
SecondaryPercent Change From Baseline in 1,25-Hydroxy Vitamin D Levels at 12 Months
Time frame:
Baseline and 12 months
Reported as:
Mean · percent change in vitamin D
Percent Change From Baseline in 1,25-Hydroxy Vitamin D Levels at 12 Months
percent change in vitamin DLanthanum Carbonate
Percent Change From Baseline in 1,25-Hydroxy Vitamin D Levels at 12 Months1.1 ± 28.6
SecondaryPercent of Subjects With Hypocalcemic Events on Calcium-based Phosphate Binder Therapy

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

Time frame:
Baseline
Reported as:
Number · percentage of subjects
Percent of Subjects With Hypocalcemic Events on Calcium-based Phosphate Binder Therapy
percentage of subjectsCalcium-based Phosphate Binder Therapy
Percent of Subjects With Hypocalcemic Events on Calcium-based Phosphate Binder Therapy10.6
SecondaryPercent of Subjects With Hypocalcemic Events on Lanthanum Carbonate

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

Time frame:
12 months
Reported as:
Number · percentage of subjects
Percent of Subjects With Hypocalcemic Events on Lanthanum Carbonate
percentage of subjectsLanthanum Carbonate
Percent of Subjects With Hypocalcemic Events on Lanthanum Carbonate22.5
SecondaryPercent of Subjects With Hypercalcemic Events on Calcium-based Phosphate Binder Therapy

Hypercalcemia is defined as total serum calcium level above 11.22 mg/dL.

Time frame:
Baseline
Reported as:
Number · percentage of subjects
Percent of Subjects With Hypercalcemic Events on Calcium-based Phosphate Binder Therapy
percentage of subjectsCalcium-based Phosphate Binder Therapy
Percent of Subjects With Hypercalcemic Events on Calcium-based Phosphate Binder Therapy0.0
SecondaryPercent of Subjects With Hypercalcemic Events on Lanthanum Carbonate

Hypercalcemia defined as total serum calcium above 11.22 mg/dL

Time frame:
12 months
Reported as:
Number · percentage of subjects
Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate
percentage of subjectsLanthanum Carbonate
Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate0.0
SecondaryChange From Baseline in Vitamin D Dose at 12 Months
Time frame:
Baseline and 12 months
Reported as:
Mean · ng
Change From Baseline in Vitamin D Dose at 12 Months
ngLanthanum Carbonate
Change From Baseline in Vitamin D Dose at 12 Months-0.7 ± 0.0075
SecondaryChange From Baseline in Mean Total Daily Dose of Calcium at 12 Months
Time frame:
Baseline and 12 months
Reported as:
Mean · mg
Change From Baseline in Mean Total Daily Dose of Calcium at 12 Months
mgLanthanum Carbonate
Change From Baseline in Mean Total Daily Dose of Calcium at 12 Months-178.6 ± 437.6
SecondaryNumber of Tablets Per Day
Time frame:
12 months
Reported as:
Mean · Number of Tablets
Number of Tablets Per Day
Number of TabletsLanthanum Carbonate
Number of Tablets Per Day3.4 ± 1.3

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lanthanum Carbonate—0/61 (0%)0/61 (0%)

Baseline characteristics

Safety Analysis Set included all screened subjects who took at least 1 dose of lanthanum carbonate and for whom 1 follow-up assessment was completed (n = 61).

Age, Continuous
Age, Continuous(years)Lanthanum Carbonate
Mean66.0 ± 12.5
Age, Customized
Age, Customized(Participants)Lanthanum Carbonate
>=18 years61
Sex: Female, Male
Sex: Female, Male(Participants)Lanthanum Carbonate
Female22
Male39
Region of Enrollment
Region of Enrollment(Participants)Lanthanum Carbonate
Germany61
08

Study locations

31 sites
  • Dialysezentrum Facharzt für Innere Medizin und Nephrologie
    Homberg, Hesse 34576, Germany
  • Dialyse Alsfeld
    Alsfeld, 36304, Germany
  • Nephrologische Praxis Altötting-Burghausen
    Altötting, 84503, Germany
  • Dialyse am Treptower Park
    Berlin, 12435, Germany
  • Dialyse Berlin
    Berlin, 12627, Germany
  • Dialysezentrum Cochem
    Cochem, 56812, Germany
  • Dialysezentrum Coesfeld
    Coesfeld, 48653, Germany
  • MVZ Caspar-David-Friedrich-Str.
    Dresden, 01217, Germany
  • Dialysezentrum Karlstraße
    Düsseldorf, 40210, Germany
  • Dialysezentrum Süd
    Düsseldorf, 40589, Germany
  • KfH-Nierenzentrum Eberswalde
    Eberswalde, 16225, Germany
  • Arzt für Dialyse, Facharzt für Innere Medizin und Nephrologie
    Essen, 45127, Germany
  • Dialysezentrum Lauerwald
    Gera, 07548, Germany
  • Dialysezentrum Grevenbroich
    Grevenbroich, 41516, Germany
  • Dialyse im Heidering
    Hannover, 30625, Germany
  • Dialysepraxen Herne und Wanne-Eickel
    Herne, 44623, Germany
  • Dialyse Herzberg
    Herzberg, 04916, Germany
  • Patienten-Heimversorgung
    Hildesheim, 31134, Germany
  • Universitätsklinik des Saarlandes
    Homburg / Saar, 66421, Germany
  • Nierenzentrum Mannheim
    Mannheim, 68309, Germany
  • Dialysepraxis
    Meiningen, 98617, Germany
  • Dialyse Mettmann
    Mettmann, 40822, Germany
  • Nierenzentrum Bogenhausen
    München, 81925, Germany
  • Nephrologie Nettetal
    Nettetal, 41334, Germany
  • Dialysenzentrum Peine
    Peine, 31224, Germany
  • Facharzt für Innere Medizin und Nephrologie
    Potsdam, 14482, Germany
  • Facharzt für Innere Medizin und Nephrologie
    Quedlinburg, 6484, Germany
  • Nephrologische Praxis Schwetzingen
    Schwetzingen, 68723, Germany
  • PHV-Dialysezentrum Siegen
    Siegen, 57076, Germany
  • Nephrologisches Zentrum
    Villingen Schwenningen, Germany
  • Dialysezentrum Worms
    Worms, 67547, Germany
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01130831
Lead sponsor
Shire
Responsible party
Sponsor
First posted
May 26, 2010
Start date
Apr 26, 2010
Primary completion
Jun 12, 2012
Completion
Jun 12, 2012
Results posted
Jul 4, 2013
Last update
Jun 28, 2021

Study contacts

Study Director
study director · Takeda
View the source record on ClinicalTrials.gov ↗

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