Paricalcitol Oral Therapy in Predialysis CKD Patients. The Greek Experience
NCT ID: NCT01083186
Last Updated: 2013-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
500 participants
OBSERVATIONAL
2009-06-30
2012-01-31
Brief Summary
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Detailed Description
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In this study, paricalcitol was prescribed on an on-label basis in an everyday setting to observe drug actions in a distinct geography (Greece with \> 250 days/year of sunny days) as well as in a significant subpopulation (Chronic Kidney Disease \[CKD\] stages 3-5 transplanted patients). Dose tolerability, treatment effects, as well as maintenance of results were registered for a 12-month period in order to obtain experience in the long term use of paricalcitol capsules. Furthermore, in centers where additional blood parameters were examined as part of clinical routine, these were recorded and analyzed.
Conditions
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Study Design
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PROSPECTIVE
Study Groups
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Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism
Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Christos Argyropoulos, MD
Role: STUDY_DIRECTOR
AbbVie Pharmaceuticals S.A.
Locations
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Site Reference ID/Investigator# 47002
Arta, , Greece
Site Reference ID/Investigator# 43772
Athens, , Greece
Site Reference ID/Investigator# 27492
Athens, , Greece
Site Reference ID/Investigator# 43769
Athens, , Greece
Site Reference ID/Investigator# 38257
Athens, , Greece
Site Reference ID/Investigator# 47003
Athens, , Greece
Site Reference ID/Investigator# 27497
Athens, , Greece
Site Reference ID/Investigator# 47004
Athens, , Greece
Site Reference ID/Investigator# 27489
Athens, , Greece
Site Reference ID/Investigator# 27495
Athens, , Greece
Site Reference ID/Investigator# 43773
Athens, , Greece
Site Reference ID/Investigator# 27498
Haidari, Athens, , Greece
Site Reference ID/Investigator# 38259
Ioannina, , Greece
Site Reference ID/Investigator# 22121
Larissa, , Greece
Site Reference ID/Investigator# 43771
Larissa, , Greece
Site Reference ID/Investigator# 43767
Maroussi Athens, , Greece
Site Reference ID/Investigator# 27496
Nikaia, , Greece
Site Reference ID/Investigator# 43768
North Ionia, Athens, , Greece
Site Reference ID/Investigator# 27491
Piraeus, , Greece
Site Reference ID/Investigator# 27494
Thessaloniki, , Greece
Site Reference ID/Investigator# 27493
Thessaloniki, , Greece
Site Reference ID/Investigator# 38255
Thessaloniki, , Greece
Site Reference ID/Investigator# 43770
Thessaloniki, , Greece
Site Reference ID/Investigator# 39839
Thessaloniki, , Greece
Countries
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Related Links
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Related info
Other Identifiers
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P11-978
Identifier Type: -
Identifier Source: org_study_id
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