Secondary HyperparathyroidismNCT01149291
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 of Secondary Hyperparathyroidism and End Stage Renal Disease, run by AbbVie (prior sponsor, Abbott) at 22 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism, End Stage Renal Disease
- How many people
- 511 participants
- Where
- 22 sitesTurkey (Türkiye)
- Study dates
- Jul 2011to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Turkey (Türkiye)22 sites
Site Reference ID/Investigator# 37822
Antalya, 07059
Site Reference ID/Investigator# 68286
Antalya, 7130
Site Reference ID/Investigator# 40677
Antalya
Site Reference ID/Investigator# 85153
Istanbul, 34180
Site Reference ID/Investigator# 40672
Istanbul
Site Reference ID/Investigator# 40674
Istanbul
Site Reference ID/Investigator# 40678
Istanbul
Site Reference ID/Investigator# 40686
Istanbul
Site Reference ID/Investigator# 61585
Istanbul
Site Reference ID/Investigator# 63764
Istanbul
Site Reference ID/Investigator# 63765
Istanbul
Site Reference ID/Investigator# 63766
Istanbul
Site Reference ID/Investigator# 69973
Istanbul
Site Reference ID/Investigator# 63763
Izmir, 7070
Site Reference ID/Investigator# 48127
Izmir
Site Reference ID/Investigator# 64444
Karaman
Site Reference ID/Investigator# 40684
Kayseri
Site Reference ID/Investigator# 48132
Konya
Site Reference ID/Investigator# 68283
Kütahya, 43260
Site Reference ID/Investigator# 68281
Mersin, 33000
Site Reference ID/Investigator# 68282
Mersin, 33000
Site Reference ID/Investigator# 69974
Mersin
About this study
Official title: 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
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.
- 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
- Medical subject headings
- Hyperparathyroidism, Secondary, Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| End stage renal disease patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (36)
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Measured: Month 0
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Measured: Month 1
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Measured: Month 2
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Measured: Month 3
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Measured: Month 4
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Measured: Month 5
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Measured: Month 6
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Measured: Month 7
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Measured: Month 8
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Measured: Month 9
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Measured: Month 10
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Measured: Month 11
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Measured: Month 12
Calcium, Phosphorus, ALP (Alkaline Phosphatase)
Measured: After early termination
Albumin, hemoglobin and dialysis adequacy (KT/V)
Measured: Month 0
Albumin, hemoglobin and dialysis adequacy (KT/V)
Measured: Month 1
Albumin, hemoglobin and dialysis adequacy (KT/V)
Measured: Month 2
Albumin, hemoglobin and dialysis adequacy (KT/V)
Measured: Month 3
Albumin, hemoglobin and dialysis adequacy (KT/V)
Measured: Month 4
Albumin, hemoglobin and dialysis adequacy (KT/V)
Measured: Month 5
Albumin, hemoglobin and dialysis adequacy (KT/V)
Measured: Month 6
Albumin, hemoglobin and dialysis adequacy (KT/V)
Measured: Month 7
Albumin, hemoglobin and dialysis adequacy (KT/V)
Measured: Month 8
Albumin, hemoglobin and dialysis adequacy (KT/V)
Measured: Month 9
Albumin, hemoglobin and dialysis adequacy (KT/V)
Measured: Month 10
Albumin, hemoglobin and dialysis adequacy (KT/V)
Measured: Month 11
Albumin, hemoglobin and dialysis adequacy (KT/V)
Measured: Month 12
Albumin, hemoglobin and dialysis adequacy (KT/V)
Measured: After early termination
hsCRP (High Sensitivity C-Reactive Protein)
Measured: Month 0
hsCRP (High Sensitivity C-Reactive Protein)
Measured: Month 3
hsCRP (High Sensitivity C-Reactive Protein)
Measured: Month 6
hsCRP (High Sensitivity C-Reactive Protein)
Measured: Month 9
hsCRP (High Sensitivity C-Reactive Protein)
Measured: Month 12
hsCRP (High Sensitivity C-Reactive Protein)
Measured: After early termination
Serious Adverse events
Measured: 18 months
Mortality data
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2010 (estimated)
- Study startJul 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary HyperparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahmut Gucuk, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149291
- Sponsor's protocol ID
- P12-314
- Status last verified
- Jan 2015
- First submitted
- 22 Jun 2010
- Last updated
- 12 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01149291
- Acronym / sponsor ID
- P12-314
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| End stage renal disease patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
36 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2015.
- Related InfoLink provided by the sponsor.
Related trials for Secondary Hyperparathyroidism
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REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Not yet recruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmut Gucuk, MD study director
AbbVie
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Hyperparathyroidism and End Stage Renal Disease, run by AbbVie (prior sponsor, Abbott) at 22 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2015.