Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT)

Study Identifier
P12-269
CT.gov Identifier
NCT01224782
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
Download document(s)

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 18 years of age or older * Patients with chronic kidney disease (CKD) stage 3 and 4 and secondary hyperparathyroidism (SHPT) * Patients with Intact Parathyroid Hormone (iPTH) \> 70 pg/mL and with chronic kidney disease (CKD) stage 3 or with Intact Parathyroid Hormone (iPTH) \> 110 pg/mL and with chronic kidney disease (CKD) stage 4 * Patients clinically indicated for treatment with Zemplar capsules * Patient must provide the authorization to use his/her data for statistical evaluation before entering to the post marketing observational study (PMOS). Local Law requirements are to be followed
    Exclusion Criteria:
    * Patients with clinically important hypercalcemia = Calcium \> 2.6 mmol/L (10.5 mg/dL) * Patients suffering from proved intoxication of vitamin D or patient with known hypersensitivity to paricalcitol or any other part of the product

    Protocol Summary

    The aims of this post-marketing observational study (PMOS) are to evaluate the time period needed to achieve \> 30% decrease of intact parathyroid hormone (iPTH) compared to the initial values and to provide data on the tolerability and compliance of treatment with Zemplar (paricalcitol) capsules in the therapy of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stage 3 or 4 in conditions of routine clinical practice.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 66544
    Montana, Bulgaria, 3400
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 47685
    Pleven, Bulgaria, 5800
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 66546
    Plovdiv, Bulgaria, 4001
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 47683
    Sofia, Bulgaria, 1257
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 66543
    Sofia, Bulgaria, 1407
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 47684
    Sofia, Bulgaria, 1431
    Status
    Not applicable
    Showing {first} - {last} of {total} Results