Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)

Study Identifier
M10-312
CT.gov Identifier
NCT00701805
EudraCT Identifier
Not available
EUCTIS ID
Not available
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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
  • Secondary Hyperparathyroidism
  • Kidney Disease
    • Study Drug
  • Paricalcitol
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    20+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Patients who completed 12 weeks of Study M10-309 (NCT00667576).
    Exclusion Criteria:
    - Patients taking drugs that affect intact parathyroid hormone (iPTH), calcium, or bone metabolism. - Patients with progressive malignancy or clinically significant hepatic disease. - Patients who developed severe cerebrovascular/cardiovascular disease during the dose-response portion of the study (i.e., during M10-309, NCT00667576). - Patients with uncontrolled diabetes during the dose-response portion of the study (i.e., during M10-309, NCT00667576).

    Protocol Summary

    The purpose of this study is to evaluate the long-term safety of paricalcitol injection.

    Subjects will administer clinical supplies 3 times a week, 40 weeks at dialysis session in

    dose-titration manner, following 12 weeks of treatment in the dose-response study, M10-309

    (NCT00667576).

    Study Locations

    Location
    Status
    Location
    Aichi, Japan
    Status
    Not applicable
    Location
    Chiba, Japan
    Status
    Not applicable
    Location
    Fukuoka, Japan
    Status
    Not applicable
    Location
    Hokkaido, Japan
    Status
    Not applicable
    Location
    Ibaragi, Japan
    Status
    Not applicable
    Location
    Kanagawa, Japan
    Status
    Not applicable
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