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Efficacy and Tolerability of Treatment With Lanthanum Carbonate in Patients With End Stage Renal Disease Receiving Dialysis

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ClinicalTrials.gov Identifier: NCT00151931
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : September 2, 2011
Sponsor:
Information provided by:
Shire

Brief Summary:
The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with lanthanum carbonate

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Drug: Lanthanum carbonate Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 456 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Centre, Open-Label Study Assessing the Efficacy and Tolerability of Lanthanum Carbonate in the Reduction of Serum Phosphate Levels in End Stage Renal Disease Patients Receiving Dialysis
Study Start Date : May 2004
Actual Study Completion Date : January 2006

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Primary Outcome Measures :
  1. Pre-dialysis serum phosphate levels at 3, 5 and 12 weeks

Secondary Outcome Measures :
  1. PTH, serum calcium and calcium-phosphorus product
  2. Treatment emergent adverse events


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females of childbearing potential agree to take adequate precautions to prevent contraception
  • Patients diagnosed with ESRD must have been receiving a stable dialysis regimen for chronic renal failure for the 2 consecutive months prior to enrollment in the study
  • Patient requires treatment for hyperphosphataemia

Exclusion Criteria:

  • Pregnant or lactating women
  • Patients who continue to require treatment with compounds containing calcium, aluminum or magnesium
  • Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma
  • Patients who are HIV+
  • Patients with any significant gastrointestinal surgery or disorders

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): NCT00151931


Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Dr. A Hutchison Department of Nephrology, Manchester Royal Infirmary

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00151931     History of Changes
Other Study ID Numbers: SPD405-313
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: September 2, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic