Study to Assess Patient Management Practices and Quality of Life With Paricalcitol Capsules in the Treatment of Secondary Hyperparathyroidism in Stage 3-5 Chronic Kidney Disease Patients Not Yet on Dialysis

Study Identifier
P12-270
CT.gov Identifier
NCT01265992
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
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Patients must sign the Informed Consent Form prior to inclusion into the study * Patients should satisfy the Swedish Summary of Product Characteristics (SPC) for paricalcitol capsules at www.fass.se * Patients must be 18 years or older with a diagnosis of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 - 5 (estimated Glomerular Filtration Rate between 10-59 by Modification of Diet in Renal Disease) but not yet on dialysis * Patients should be in stable condition and have a life expectancy of at least 6 months * Patients should not be expected to be transplanted or initiate dialysis for at least 6 months
    Exclusion Criteria:
    * Patients with CKD receiving dialysis * Patients contraindicated for paricalcitol capsules as described in the SPC * Treatment with paricalcitol more than 20 days prior to study enrollment * History of drug or alcohol abuse within 6 months prior to inclusion * History of non-compliance with medication or a medical history (i.e. psychiatric) that could enhance non-compliance with medication as determined by the investigator

    Protocol Summary

    Paricalcitol capsules (Zemplar®) received marketing authorization in Sweden in late 2007 for the prevention and treatment of secondary hyperparathyroidism in patients with Stage 3 \& 4 Chronic Kidney Disease (CKD). Accordingly, additional data is needed to evaluate the effectiveness and safety of paricalcitol therapy under conditions of usual clinical care in Sweden.

    This observational study is designed to collect data to evaluate safety and effectiveness during 6 months of therapy with paricalcitol capsules prescribed for patients with CKD Stages 3-5 not yet on dialysis. Data will also be collected on patient quality of life and costs associated with patient care.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 47723
    Kalmar, Sweden, 391 85
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 41084
    Karlstad, Sweden, 651 85
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 45190
    Kristianstad, Sweden, 291 85
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 41085
    Linköping, Sweden, 581 85
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 41087
    Norrköping, Sweden, 601 82
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 45188
    Örebro, Sweden, 701 85
    Status
    Not applicable
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