CompletedNCT01149291Updated Jan 12, 2015

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

An observational study in Secondary Hyperparathyroidism and End Stage Renal Disease, sponsored by AbbVie (prior sponsor, Abbott). Completed at 22 sites in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-12.

Sponsored by AbbVie (prior sponsor, Abbott) · Observational

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 511
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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 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:

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.

Secondary aims are:

To observe changes in commonly assessed biochemical parameters for bone and mineral metabolism (Ca (Calcium), P (Phosphorus), ALP (Alkaline phosphatase) and additionally hsCRP (high sensitivity C-reactive protein) as cardiovascular inflammatory marker.
To evaluate routinely checked parameters like albumin, hemoglobin and dialysis adequacy (KT/V).
To collect and evaluate data from all adverse events in order to establish the safety profile of sVDRA(Selective Vitamin D Receptor Activator) in daily clinical practice.
To collect mortality data 6 months after 12 months of observational period or 6 months after drop out.

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.

Conditions studied

Secondary Hyperparathyroidism
End Stage Renal Disease

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Keywords

high sensitivity C-reactive protein (hsCRP)
cardiorenal
end stage renal disease (ESRD)
Secondary hyperparathyroidism (SHPT)
dialysis
paricalcitol
osteodystrophy
selective Vitamin D receptor activators (sVDRA)
chronic kidney disease

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's enrollment of 511 is above the median of 121 across 594 observational studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

AbbVie (prior sponsor, Abbott) is the lead sponsor of 215 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

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.

Inclusion criteria

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 criteria

Exclusion Criteria:

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)

Study design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 511 participants (actual)

Groups and cohorts

End stage renal disease patients

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

22 sites

Site Reference ID/Investigator# 37822
Antalya, 07059, Turkey
Site Reference ID/Investigator# 68286
Antalya, 7130, Turkey
Site Reference ID/Investigator# 40677
Antalya, Turkey
Site Reference ID/Investigator# 85153
Istanbul, 34180, Turkey
Site Reference ID/Investigator# 40672
Istanbul, Turkey
Site Reference ID/Investigator# 40674
Istanbul, Turkey
Site Reference ID/Investigator# 40678
Istanbul, Turkey
Site Reference ID/Investigator# 40686
Istanbul, Turkey
Site Reference ID/Investigator# 61585
Istanbul, Turkey
Site Reference ID/Investigator# 63764
Istanbul, Turkey
Site Reference ID/Investigator# 63765
Istanbul, Turkey
Site Reference ID/Investigator# 63766
Istanbul, Turkey
Site Reference ID/Investigator# 69973
İstanbul, Turkey
Site Reference ID/Investigator# 63763
Izmir, 7070, Turkey
Site Reference ID/Investigator# 48127
Izmir, Turkey
Site Reference ID/Investigator# 64444
Karaman, Turkey
Site Reference ID/Investigator# 40684
Kayseri, Turkey
Site Reference ID/Investigator# 48132
Konya, Turkey
Site Reference ID/Investigator# 68283
Kutahya, 43260, Turkey
Site Reference ID/Investigator# 68281
Mersin, 33000, Turkey
Site Reference ID/Investigator# 68282
Mersin, 33000, Turkey
Site Reference ID/Investigator# 69974
Mersin, Turkey

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01149291
Lead sponsor: AbbVie (prior sponsor, Abbott)
Responsible party: Sponsor
First posted: Jun 23, 2010
Start date: Jul 2011
Primary completion: Dec 2014
Completion: Dec 2014
Last update: Jan 12, 2015

Study contacts

Mahmut Gucuk, MD

study director · AbbVie

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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