Status:
COMPLETED
Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT)
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Chronic Kidney Disease
Secondary Hyperparathyroidism
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed Description
This is a non-interventional, observational, open-label, multi-country, multicenter post-marketing study in which Zemplar (paricalcitol) is prescribed in the usual manner in accordance with the terms ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
994 Patients enrolled
Trial Details
Trial ID
NCT01224782
Start Date
October 1 2010
End Date
August 1 2013
Last Update
September 15 2014
Active Locations (69)
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1
Site Reference ID/Investigator# 66544
Montana, Bulgaria, 3400
2
Site Reference ID/Investigator# 47685
Pleven, Bulgaria, 5800
3
Site Reference ID/Investigator# 66546
Plovdiv, Bulgaria, 4001
4
Site Reference ID/Investigator# 47683
Sofia, Bulgaria, 1257