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
A 18 Months, Post-marketing Observational Study to Follow-up Patients With End Stage Renal Disease Undergoing Hemodialysis, Receiving sVDRA's for Prevention and Treatment of Secondary Hyperparathyroidism
1 other identifier
observational
511
1 country
22
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 clinical setting and according to the approved Summary of Product Characteristics for the treatment of secondary hyperparathyroidism in hemodialysis patients in Turkey. The relation of the safety data to PTH (Parathyroid hormone) suppression over time will be evaluated. Also the number and incidence of hypercalcemia and hyperphosphatemia will be recorded.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2011
Typical duration for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2010
CompletedFirst Posted
Study publicly available on registry
June 23, 2010
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJanuary 12, 2015
January 1, 2015
3.4 years
June 22, 2010
January 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess percentage change in iPTH (intact Parathyroid Hormone) level monthly among hemodialysis patients with SHPT (Secondary Hyperparathyroidism) receiving sVDRA (Selective Vitamin D Receptor Activator) therapy
12 months
Secondary Outcomes (36)
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Month 0
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Month 1
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Month 2
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Month 3
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Month 4
- +31 more secondary outcomes
Study Arms (1)
End stage renal disease patients
Eligibility Criteria
ESRD (End Stage Renal Disease) patients undergoing hemodialysis who at the time of entry are receiving sVDRA's (Selective Vitamin D Receptor Activator) as it is prescribed in the normal clinical setting and according to the approved SmPC (Summary of Product Characteristics) for the prevention or treatment of secondary hyperparathyroidism.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Site Reference ID/Investigator# 37822
Antalya, 07059, Turkey (Türkiye)
Site Reference ID/Investigator# 68286
Antalya, 7130, Turkey (Türkiye)
Site Reference ID/Investigator# 40677
Antalya, Turkey (Türkiye)
Site Reference ID/Investigator# 85153
Istanbul, 34180, Turkey (Türkiye)
Site Reference ID/Investigator# 40672
Istanbul, Turkey (Türkiye)
Site Reference ID/Investigator# 40674
Istanbul, Turkey (Türkiye)
Site Reference ID/Investigator# 40678
Istanbul, Turkey (Türkiye)
Site Reference ID/Investigator# 40686
Istanbul, Turkey (Türkiye)
Site Reference ID/Investigator# 61585
Istanbul, Turkey (Türkiye)
Site Reference ID/Investigator# 63764
Istanbul, Turkey (Türkiye)
Site Reference ID/Investigator# 63765
Istanbul, Turkey (Türkiye)
Site Reference ID/Investigator# 63766
Istanbul, Turkey (Türkiye)
Site Reference ID/Investigator# 69973
Istanbul, Turkey (Türkiye)
Site Reference ID/Investigator# 63763
Izmir, 7070, Turkey (Türkiye)
Site Reference ID/Investigator# 48127
Izmir, Turkey (Türkiye)
Site Reference ID/Investigator# 64444
Karaman, Turkey (Türkiye)
Site Reference ID/Investigator# 40684
Kayseri, Turkey (Türkiye)
Site Reference ID/Investigator# 48132
Konya, Turkey (Türkiye)
Site Reference ID/Investigator# 68283
Kütahya, 43260, Turkey (Türkiye)
Site Reference ID/Investigator# 68281
Mersin, 33000, Turkey (Türkiye)
Site Reference ID/Investigator# 68282
Mersin, 33000, Turkey (Türkiye)
Site Reference ID/Investigator# 69974
Mersin, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mahmut Gucuk, MD
AbbVie
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2010
First Posted
June 23, 2010
Study Start
July 1, 2011
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
January 12, 2015
Record last verified: 2015-01