Status:
COMPLETED
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
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborating Sponsors:
Pharma Consulting Group AB
Conditions:
Secondary Hyperparathyroidism
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed Description
This observational study is designed to collect data to evaluate safety and effectiveness during 6 months of therapy with paricalcitol capsules prescribed in accordance with the terms of the marketing...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01265992
Start Date
February 1 2011
End Date
November 1 2012
Last Update
February 19 2014
Active Locations (10)
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1
Site Reference ID/Investigator# 47723
Kalmar, Sweden, 391 85
2
Site Reference ID/Investigator# 41084
Karlstad, Sweden, 651 85
3
Site Reference ID/Investigator# 45190
Kristianstad, Sweden, 291 85
4
Site Reference ID/Investigator# 41085
Linköping, Sweden, 581 85