Status:
COMPLETED
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
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Secondary Hyperparathyroidism
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Brief 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 cli...
Detailed Description
The scientific purpose of this study is to obtain data on the use of sVDRA(Selective Vitamin D Receptor Activator) in real-life clinical practice. This study will allow us to observe drug effectivenes...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
511 Patients enrolled
Trial Details
Trial ID
NCT01149291
Start Date
July 1 2011
End Date
December 1 2014
Last Update
January 12 2015
Active Locations (22)
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1
Site Reference ID/Investigator# 37822
Antalya, Turkey (Türkiye), 07059
2
Site Reference ID/Investigator# 68286
Antalya, Turkey (Türkiye), 7130
3
Site Reference ID/Investigator# 40677
Antalya, Turkey (Türkiye)
4
Site Reference ID/Investigator# 85153
Istanbul, Turkey (Türkiye), 34180