A Study to Follow-up Patients With End Stage Renal Disease Undergoing Hemodialysis, Receiving Selective Vitamin D Receptor Activator's for Prevention and Treatment of Secondary Hyperparathyroidism

Study Identifier
P12-314
CT.gov Identifier
NCT01149291
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
  • 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 5 and receiving hemodialysis who is treated with sVDRA's (Selective Vitamin D Receptor Activator) injection * iPTH (intact parathyroid hormone) \>300pg/ml, corrected serum Ca (Calcium) \< 10.2 mg/dl, serum P (Phosphorus) \< 6 mg/dl * Male and female (not pregnant or not planning to be pregnant in the next 12 months) patients equal to or older than 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:
    * Subject has known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients * Subject has participated in a clinical study within the last month * If sVDRA's (Selective Vitamin D Receptor Activator) are contraindicated according to the SmPC (Summary of Product Characteristics)

    Protocol Summary

    The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of selective Vitamin D Receptor Activator's as it is prescribed in the normal clinical setting and according to the approved Summary of Product Characteristics for the treatment of secondary hyperparathyroidism in hemodialysis patients in Turkey. The relation of the safety data to PTH (Parathyroid hormone) suppression over time will be evaluated. Also the number and incidence of hypercalcemia and hyperphosphatemia will be recorded.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 37822
    Antalya, Turkey, 07059
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 68286
    Antalya, Turkey, 7130
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 40677
    Antalya, Turkey
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 85153
    Istanbul, Turkey, 34180
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 40672
    Istanbul, Turkey
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 40674
    Istanbul, Turkey
    Status
    Not applicable
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