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
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Study Details
Medical Condition
Study Phase
Intervention Type
Date
Participation Requirements
Gender
Age
Healthy Volunteers
Inclusion Criteria
Exclusion Criteria
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| Location | Status | Site Contact Details |
|---|---|---|
Location Site Reference ID/Investigator# 37822, Antalya, 07059 | Status Not Available | |
Location Site Reference ID/Investigator# 68286, Antalya, 7130 | Status Not Available | |
Location Site Reference ID/Investigator# 40677, Antalya | Status Not Available | |
Location Site Reference ID/Investigator# 85153, Istanbul, 34180 | Status Not Available | |
Location Site Reference ID/Investigator# 40672, Istanbul | Status Not Available | |
Location Site Reference ID/Investigator# 40674, Istanbul | Status Not Available | |
Location Site Reference ID/Investigator# 40678, Istanbul | Status Not Available | |
Location Site Reference ID/Investigator# 40686, Istanbul | Status Not Available | |
Location Site Reference ID/Investigator# 61585, Istanbul | Status Not Available | |
Location Site Reference ID/Investigator# 63764, Istanbul | Status Not Available | |
Location Site Reference ID/Investigator# 63765, Istanbul | Status Not Available | |
Location Site Reference ID/Investigator# 63766, Istanbul | Status Not Available | |
Location Site Reference ID/Investigator# 69973, İstanbul | Status Not Available | |
Location Site Reference ID/Investigator# 63763, Izmir, 7070 | Status Not Available | |
Location Site Reference ID/Investigator# 48127, Izmir | Status Not Available | |
Location Site Reference ID/Investigator# 64444, Karaman | Status Not Available | |
Location Site Reference ID/Investigator# 40684, Kayseri | Status Not Available | |
Location Site Reference ID/Investigator# 48132, Konya | Status Not Available | |
Location Site Reference ID/Investigator# 68283, Kutahya, 43260 | Status Not Available | |
Location Site Reference ID/Investigator# 68281, Mersin, 33000 | Status Not Available | |
Location Site Reference ID/Investigator# 68282, Mersin, 33000 | Status Not Available | |
Location Site Reference ID/Investigator# 69974, Mersin | Status Not Available |
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.
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
Time Frame: 12 months
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 0
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 1
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 2
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 3
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 4
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 5
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 6
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 7
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 8
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 9
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 10
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 11
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: Month 12
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Time Frame: After early termination
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 0
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 1
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 2
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 3
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 4
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 5
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 6
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 7
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 8
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 9
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 10
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 11
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: Month 12
Albumin, hemoglobin and dialysis adequacy (KT/V)
Time Frame: After early termination
hsCRP (High Sensitivity C-Reactive Protein)
Time Frame: Month 0
hsCRP (High Sensitivity C-Reactive Protein)
Time Frame: Month 3
hsCRP (High Sensitivity C-Reactive Protein)
Time Frame: Month 6
hsCRP (High Sensitivity C-Reactive Protein)
Time Frame: Month 9
hsCRP (High Sensitivity C-Reactive Protein)
Time Frame: Month 12
hsCRP (High Sensitivity C-Reactive Protein)
Time Frame: After early termination
Serious Adverse events
Time Frame: 18 months
Mortality data
Time Frame: 18 months
Interventions:
- Not Available
Enrollment:
511
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