Study to Compare Initial Dosing Parameters of Zemplar in Stage V Chronic Kidney Disease Subjects on Hemodialysis

Study Identifier
M01-367
CT.gov Identifier
NCT00091481
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Kidney Disease
    • Study Drug
  • Zemplar
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    20+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Inclusion Criteria: - Stage V Chronic Kidney Disease - Patients on Hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin D therapy

    Protocol Summary

    To show non-inferiority in the incidence rates of elevated calcium-phosphorus product between

    two treatment groups: 1) a group having an initial dose based on baseline PTH (baseline

    iPTH/80) and 2) a group having a starting dose based on body weight (0.04 mcg/kg).

    Study Locations

    Location
    Status
    Location
    Errikos Dynan Hospital
    Ambelokipi, Athens, Greece, 11526
    Status
    Not applicable
    Location
    General Hospital of Athens, "G.Gennimatas"
    Holargos, Athens, Greece, 11527
    Status
    Not applicable
    Location
    General Hospital of Attica "Sismanoglio"
    Marousi, Athens, Greece, 15126
    Status
    Not applicable
    Location
    "Hygeia" Diagnosis and Therapy Center
    Marousi, Athens, Greece, 152 00
    Status
    Not applicable
    Location
    General Hospital of Melissia "Amalia Fleming"
    Melissia, Athens, Greece, 15127
    Status
    Not applicable
    Location
    General Hospital of Voula Askilpieion
    Voula, Athens, Greece, 16673
    Status
    Not applicable
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