Paricalcitol Oral Therapy in Predialysis CKD Patients. The Greek Experience

Study Identifier
P11-978
CT.gov Identifier
NCT01083186
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Kidney Disease
  • Secondary Hyperparathyroidism
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Patients with secondary hyperparathyroidism in the presence of chronic kidney disease stage 3, 4 or 5 treated with Zemplar (paricalcitol) oral for at least 1 month prior to study enrollment * Male and female (not pregnant or not planning to be pregnant in the next 12 months) patients \> 18 years of age * Signed informed consent by subject * Hypertensive and diabetic subjects must be on an optimal and steady medication regimen for more than 30 days
    Exclusion Criteria:
    * Contraindications listed in the Summary of Product Characteristics for Zemplar capsules apply (Appendix I and II) * Parathormone value of \> 1000 pg/mL (sign of tertiary hyperparathyroidism) * Treatment with Vitamin D within the last 1 month prior to inclusion into the study

    Protocol Summary

    The purpose of this study is to obtain data on the use of Zemplar (paricalcitol) capsules in real-life clinical practice in predialysis patients with chronic kidney disease (CKD) and secondary hyperparathyroidism.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 47002
    Arta, Greece, 47100
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 43772
    Athens, Greece, 115 21
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 27492
    Athens, Greece, 115 27
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 43769
    Athens, Greece, 115 27
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 38257
    Athens, Greece, 11526
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 47003
    Athens, Greece, 11526
    Status
    Not applicable
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