Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism

Study Identifier
M11-517
CT.gov Identifier
NCT01341782
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
  • maxacalcitol
  • paricalcitol placebo
  • maxacalcitol placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    20+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Adult Chronic Kidney Disease (CKD) Stage 5 patients undergoing dialysis with stable dialysate calcium and phosphate binders * On three times weekly hemodialysis for at least 3 months prior with intact parathyroid hormone (iPTH) greater than or equal to 300 pg/mL, adjusted normalized serum total calcium (Ca) greater than or equal to 8.4 to less than 10.2 mg/dL, serum phosphorus (P) less than or equal to 6.5 mg/dL.
    Exclusion Criteria:
    * Patients with a recent history of severe cardiovascular or hepatic disease, uncontrolled hypertension or uncontrolled diabetes * Patients who have received a parathyroidectomy or ethanol infusion within the prior year * Patients taking drugs that affect iPTH, calcium or bone metabolism * Patients who will need to take chronic doses (greater than or equal to 2 consecutive weeks) of cytochrome P450 inhibitors (e.g., clarithromycin, grapefruit products) or inducers (e.g., carbamazepine, rifampicin) * Female patients who are pregnant, possibly pregnant, wish to become pregnant, or participate in breastfeeding during the study period.

    Protocol Summary

    This study is a comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in adult Japanese chronic kidney disease patients receiving hemodialysis with secondary hyperparathyroidism. The main objective of this study is to demonstrate the efficacy of paricalcitol injection in reducing levels of parathyroid hormone without clinically significant hypercalcemia, compared to maxacalcitol injection.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 53485
    Aichi, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 51571
    Chiba, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 52963
    Chiba, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 52966
    Chiba, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 51578
    Gifu, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 52965
    Gunma, Japan
    Status
    Not applicable
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