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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.
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 effectiveness in a distinct geography. Treatment effects, as well as maintenance of the results will be recorded for a 18 months period in order to obtain experience in the long term use of sVDRA(Selective Vitamin D Receptor Activator). Furthermore in the centers, additional blood parameter, hsCRP (high sensitivity C-reactive protein), will be examined as part of the clinical routine.
The primary aim of the study is:
Secondary aims are:
Patients will be followed for 12 months within the post-marketing observational study and will be checked for mortality data 6 months after this follow up period. The enrollment period should not exceed 6 months.
All demographic information will be summarized by using descriptive statistics and graphs. Laboratory levels will be assessed by using mean, median, minimum, maximum, standard deviation and percentages on visit basis. The mean differences on laboratory levels between visits will also be summarized by graphics and assessed by using percentages.
Alkaline phosphatase and hsCRP (high sensitivity C-reactive protein) levels will also be summarized by using descriptive statistics and graphs per visit.
sVDRA (Selective Vitamin D Receptor Activator) dose changes per visits will be summarized by descriptive statistics and graphs.
Mortality will be analyzed with life tables. By taking into account the primary and secondary aims of the study, to be able to achieve the therapeutic success on iPTH (intact parathyroid hormone) level changes with sVDRA (Selective Vitamin D Receptor Activator) treatment and perform mortality assessment in following 6 months and collect data regarding safety and efficacy of sVDRAs (Selective Vitamin D Receptor Activators) in long term use, it has been determined to enroll totally 510 patients from 30 sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| End stage renal disease patients |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Calcium, Phosphorus, ALP (Alkaline Phosphatase) | Month 0 | |
| Calcium, Phosphorus, ALP (Alkaline Phosphatase) | Month 1 | |
| Calcium, Phosphorus, ALP (Alkaline Phosphatase) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Mahmut Gucuk, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 37822 | Antalya | 07059 | Turkey (Türkiye) | |||
| Site Reference ID/Investigator# 68286 |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Month 2 |
| Calcium, Phosphorus, ALP (Alkaline Phosphatase) | Month 3 |
| Calcium, Phosphorus, ALP (Alkaline Phosphatase) | Month 4 |
| Calcium, Phosphorus, ALP (Alkaline Phosphatase) | Month 5 |
| Calcium, Phosphorus, ALP (Alkaline Phosphatase) | Month 6 |
| Calcium, Phosphorus, ALP (Alkaline Phosphatase) | Month 7 |
| Calcium, Phosphorus, ALP (Alkaline Phosphatase) | Month 8 |
| Calcium, Phosphorus, ALP (Alkaline Phosphatase) | Month 9 |
| Calcium, Phosphorus, ALP (Alkaline Phosphatase) | Month 10 |
| Calcium, Phosphorus, ALP (Alkaline Phosphatase) | Month 11 |
| Calcium, Phosphorus, ALP (Alkaline Phosphatase) | Month 12 |
| Calcium, Phosphorus, ALP (Alkaline Phosphatase) | After early termination |
| Albumin, hemoglobin and dialysis adequacy (KT/V) | Month 0 |
| Albumin, hemoglobin and dialysis adequacy (KT/V) | Month 1 |
| Albumin, hemoglobin and dialysis adequacy (KT/V) | Month 2 |
| Albumin, hemoglobin and dialysis adequacy (KT/V) | Month 3 |
| Albumin, hemoglobin and dialysis adequacy (KT/V) | Month 4 |
| Albumin, hemoglobin and dialysis adequacy (KT/V) | Month 5 |
| Albumin, hemoglobin and dialysis adequacy (KT/V) | Month 6 |
| Albumin, hemoglobin and dialysis adequacy (KT/V) | Month 7 |
| Albumin, hemoglobin and dialysis adequacy (KT/V) | Month 8 |
| Albumin, hemoglobin and dialysis adequacy (KT/V) | Month 9 |
| Albumin, hemoglobin and dialysis adequacy (KT/V) | Month 10 |
| Albumin, hemoglobin and dialysis adequacy (KT/V) | Month 11 |
| Albumin, hemoglobin and dialysis adequacy (KT/V) | Month 12 |
| Albumin, hemoglobin and dialysis adequacy (KT/V) | After early termination |
| hsCRP (High Sensitivity C-Reactive Protein) | Month 0 |
| hsCRP (High Sensitivity C-Reactive Protein) | Month 3 |
| hsCRP (High Sensitivity C-Reactive Protein) | Month 6 |
| hsCRP (High Sensitivity C-Reactive Protein) | Month 9 |
| hsCRP (High Sensitivity C-Reactive Protein) | Month 12 |
| hsCRP (High Sensitivity C-Reactive Protein) | After early termination |
| Serious Adverse events | 18 months |
| Mortality data | 18 months |
| 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) |
| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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