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Efficacy and Safety of Lanthanum in Controlling Serum Phosphate Levels in Subjects With End Stage Renal Disease Who Require Treatment for High Levels of Phosphate in Their Blood

Primary Purpose

Kidney Failure, Chronic

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Lanthanum carbonate
Sponsored by
Shire
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects with ESRD who currently require treatment for hyperphosphatemia Women of childbearing potential must have a negative serum beta HCG pregnancy test and must agree to abstain from sexual activity or to use acceptable contraceptives from the time of informed consent throughout the study Exclusion Criteria: Treatment with compounds containing calcium, aluminum or magnesium for use as a phosphate binder Hypocalcaemia Treatment-naive to any phosphate binder with a serum phosphorus < 5.5 mg/dL Any significant gastrointestinal surgery or gastrointestinal disorders

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Pre-dialysis serum phosphate levels after 4 and 8 weeks of treatment

    Secondary Outcome Measures

    Tolerability
    Quality of Life
    Subject/physician satisfaction and preference questionnaires

    Full Information

    First Posted
    September 6, 2005
    Last Updated
    June 4, 2021
    Sponsor
    Shire
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00150566
    Brief Title
    Efficacy and Safety of Lanthanum in Controlling Serum Phosphate Levels in Subjects With End Stage Renal Disease Who Require Treatment for High Levels of Phosphate in Their Blood
    Official Title
    A Phase IIIb, Multi-center, Two-Cohort, Randomized Study, With an Open-Label Run-In and a Long-Term Extensions Phase, Assessing an Extended Dose Range of Lanthanum Carbonate in End Stage Renal Disease Subjects Receiving Hemodialysis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    February 9, 2004 (Actual)
    Primary Completion Date
    October 8, 2005 (Actual)
    Study Completion Date
    October 8, 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shire

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to test how well higher doses of lanthanum carbonate reduce the pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Failure, Chronic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    460 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Lanthanum carbonate
    Primary Outcome Measure Information:
    Title
    Pre-dialysis serum phosphate levels after 4 and 8 weeks of treatment
    Time Frame
    4 & 8 weeks
    Secondary Outcome Measure Information:
    Title
    Tolerability
    Time Frame
    8 weeks
    Title
    Quality of Life
    Time Frame
    8 weeks
    Title
    Subject/physician satisfaction and preference questionnaires
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects with ESRD who currently require treatment for hyperphosphatemia Women of childbearing potential must have a negative serum beta HCG pregnancy test and must agree to abstain from sexual activity or to use acceptable contraceptives from the time of informed consent throughout the study Exclusion Criteria: Treatment with compounds containing calcium, aluminum or magnesium for use as a phosphate binder Hypocalcaemia Treatment-naive to any phosphate binder with a serum phosphorus < 5.5 mg/dL Any significant gastrointestinal surgery or gastrointestinal disorders
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Study Director
    Organizational Affiliation
    Takeda
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18579668
    Citation
    Mehrotra R, Martin KJ, Fishbane S, Sprague SM, Zeig S, Anger M; Fosrenol Overview Research Evaluation Study for Early Experience Study Group. Higher strength lanthanum carbonate provides serum phosphorus control with a low tablet burden and is preferred by patients and physicians: a multicenter study. Clin J Am Soc Nephrol. 2008 Sep;3(5):1437-45. doi: 10.2215/CJN.04741107. Epub 2008 Jun 25.
    Results Reference
    result
    Links:
    URL
    http://www.fda.gov/opacom/7alerts.html
    Description
    FDA Recall Information

    Learn more about this trial

    Efficacy and Safety of Lanthanum in Controlling Serum Phosphate Levels in Subjects With End Stage Renal Disease Who Require Treatment for High Levels of Phosphate in Their Blood

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