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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01130831
Recruitment Status : Completed
First Posted : May 26, 2010
Results First Posted : July 4, 2013
Last Update Posted : July 26, 2013
Sponsor:
Information provided by (Responsible Party):
Shire

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.

Condition or disease Intervention/treatment
End Stage Renal Disease Drug: Lanthanum carbonate

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Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : May 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Lanthanum carbonate
    Other Name: Fosrenol


Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Haemodialysis patients with hyperphosphataemia
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130831


Locations
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Sponsors and Collaborators
Shire
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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01130831    
Other Study ID Numbers: SPD405-702
First Posted: May 26, 2010    Key Record Dates
Results First Posted: July 4, 2013
Last Update Posted: July 26, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency