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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00151931
First Posted: September 9, 2005
Last Update Posted: September 2, 2011
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.
Information provided by:
Shire
  Purpose
The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with lanthanum carbonate

Condition Intervention Phase
Kidney Failure, Chronic Drug: Lanthanum carbonate Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Shire:

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

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

Estimated Enrollment: 456
Study Start Date: May 2004
Study Completion Date: January 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00151931     History of Changes
Other Study ID Numbers: SPD405-313
First Submitted: September 7, 2005
First Posted: September 9, 2005
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