Study to Evaluate the Effect of Intravenous (IV) Paricalcitol (Zemplar) on Cardiac Morbidity in Patients With Chronic Kidney Disease (CKD) Stage 5 Over 2 Years

Study Identifier
P10-680
CT.gov Identifier
NCT01073462
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
  • Secondary Hyperparathyroidism
  • Kidney Disease
  • Cardiovascular Disease
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Patients aged at least 18 years * Patients with secondary hyperparathyroidism associated with CKD stage 5, serum iPTH \> 150 pg/mL, * Cardiac disease as described by Medical Dictionary for Regulatory Activities (MedDRA) terms: * cardiac disorder as cardiac arrhythmias * cardiac disorder signs and symptoms * cardiac neoplasm * cardiac valve disorder * heart failures * myocardial disorder * pericardial disorder * Serum phosphate level \< 6.5 mg/dL and serum calcium level \< 10.5 mg/dL
    Exclusion Criteria:
    * Patients who meet contraindications as outlined in the latest version of Zemplar (Paricalcitol IV) summary of product characteristics * Patients with known hypersensitivity to paricalcitol or any component of the formulation, vitamin D intoxication, hypercalcemia; cinacalcet as concomitant medication.

    Protocol Summary

    The purpose of this study was to ascertain the percentage of cardiac patients with chronic kidney disease (CKD) stage 5 treated with paricalcitol IV achieving intact parathyroid hormone (iPTH) levels in target range of Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines (150 - 300 pg/mL) after 2 years.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 27447
    Graz, Austria, 8010
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 49182
    Graz, Austria, 8020
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 27483
    Graz, Austria, 80360
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 52742
    Graz, Austria, 8052
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 27487
    Innsbruck, Austria, 6020
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 36983
    Linz, Austria, 4010
    Status
    Not applicable
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