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Completed

NCT Number: NCT01130831

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dialysezentrum Facharzt für Innere Medizin und Nephrologie, Homberg (Ohm), Hesse, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Lanthanum carbonate

Drug

Other names: Fosrenol

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  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

    Time frame: Baseline

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

  16. 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

  17. 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.

  18. Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate

    Time frame: 12 months

    Hypercalcemia defined as total serum calcium above 11.22 mg/dL

  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

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 26, 2010
Registry last updated
Jun 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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