Chronic Kidney DiseaseQUALITIZENCT01368042

Quality of Life in Greek Hemodialysis Patients Receiving Zemplar Intravenous

An observational study of Chronic Kidney Disease and Secondary Hyperparathyroidism, run by AbbVie (prior sponsor, Abbott) at 11 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess health-related Quality of Life (QoL) changes in participants with chronic kidney disease (CKD) and secondary hyperparathyroidism (sHPT) undergoing hemodialysis and receiving paricalcitol intravenous (iv). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Disease, Secondary Hyperparathyroidism
Type of treatment: Injection or infusion
How many people: 265 participants
Where: 11 sitesGreece
Study dates: Aug 2011to Jun 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: Patients with chronic kidney disease stage 5 on hemodialysis and diagnosed with secondary hyperparathyroidism, who were prescribed paricalcitol intravenous according to the approved Summary of Product Characteristics

Who may be able to join

Patients with chronic kidney disease stage 5 undergoing hemodialysis and receiving paricalcitol iv for more than 1 month.
Patients with a RAND 36-Item Health Survey completed 10 to 35 days before paricalcitol iv initiation
Patients with baseline parathormone ≥ 300 pg/mL
Patients willing to give their informed consent to participate in the study.
Patients should not receive vitamin D-related compounds or cinacalcet for 3 months prior to entering the study
Patients must be on steady regimen for anemia, hypertension and diabetes for the past 30 days

Who cannot join

Patients with a history of clinically significant intolerance or sensitivity to vitamin D or any ingredients of the product.
Patients with persistent hypercalcemia or evidence of vitamin D toxicity.
Patients with a continuous increase in serum (calcium x phosphorus) product greater than 65.
Pregnant or lactating female patients.
Patients who have previously undergone parathyroidectomy

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

Greece11 sites

Site Reference ID/Investigator# 56803
Arta, 47100
Site Reference ID/Investigator# 53424
Athens, 11528
Site Reference ID/Investigator# 53425
Larissa, 41223
Site Reference ID/Investigator# 56805
Lefkada, 31100
Site Reference ID/Investigator# 56802
Melíssia, 151 27
Site Reference ID/Investigator# 66291
Pátrai, 26225
Site Reference ID/Investigator# 56809
Pátrai, 26504
Site Reference ID/Investigator# 50442
Pylaia Thessaloniki, 57001
Site Reference ID/Investigator# 77554
Thessaloniki, 570 01,
Site Reference ID/Investigator# 77553
Thessaloniki, 570 19
Site Reference ID/Investigator# 53422
Volos, 38221

Other trials in Greece

About this study

Official title: Quality of Life in Greek Hemodialysis Patients Receiving Zemplar i.v (QualitiZe)

Read the detailed description

The scientific purpose of this study is to obtain data on the use of paricalcitol iv in real-life clinical practice and the effect it has on participant health-related QoL. In this study, paricalcitol iv will be prescribed on an on-label basis in an everyday setting. The RAND 36-Item Health Survey results will be collected for a 6-month period (every 3 months) in order to assess the effect of paricalcitol iv on participant health-related QoL.

Conditions: Chronic Kidney Disease, Secondary Hyperparathyroidism
Keywords: Quality of Life changes, Secondary Hyperparathyroidism, Chronic Kidney Disease, Hemodialysis, Paricalcitol intravenous treatment
Medical subject headings: Renal Insufficiency, Chronic, Hyperparathyroidism, Secondary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01368042
Study group	Role	What they receive
Chronic Kidney Disease, Secondary Hyperpathyroidism		All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Physical Functioning' Scale Scores
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including physical functioning. The scores for each scale range from 0 to 100, with 0 representing the worst possible state of physical functioning and 100 representing the best possible state of physical functioning. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Measured: Baseline, 6 months post-enrollment
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Physical Health' Scale Scores
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including role limitations due to physical health. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Measured: Baseline, 6 months post-enrollment
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Emotional Problems' Scale Scores
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including role limitations due to emotional problems. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Measured: Baseline, 6 months post-enrollment
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Energy/Fatigue' Scale Scores
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including energy/fatigue. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Measured: Baseline, 6 months post-enrollment
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Emotional Well-Being' Scale Scores
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including emotional well-being. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Measured: Baseline, 6 months post-enrollment
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Social Functioning' Scale Scores
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including social functioning. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Measured: Baseline, 6 months post-enrollment
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Bodily Pain' Scale Scores
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including bodily pain. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Measured: Baseline, 6 months post-enrollment
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'General Health Perceptions' Scale Scores
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including general health perceptions. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Measured: Baseline, 6 months post-enrollment
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Health Change' Item Scores
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes a single question pertaining to the participant's health change over the last year. The scores range from 0 to 100, with 100: much better than 1 year ago; 75: somewhat better than 1 year ago; 50: about the same; 25: somewhat worse than 1 year ago; 0: much worse than 1 year ago. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Measured: Baseline, 6 months post-enrollment
Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, bodily pain, general health perception, health change). Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the enrollment and post-enrollment visits was calculated as the visit score minus the baseline score. Linear models based on Generalized Estimating Equations (GEE) were used to assess the effect of time on change from baseline through enrollment, 3 months post-enrollment, and 6 months post-enrollment.
Measured: Baseline, enrollment, 3 months post-enrollment, 6 months post-enrollment

Secondary outcomes (7)

Change From Enrollment to 6 Months Post-enrollment in Urea Levels (mg/dL)
Urea levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.
Measured: Enrollment, 6 months post-enrollment
Change From Enrollment to 6 Months Post-enrollment in Creatinine Levels (mg/dL)
Creatinine levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.
Measured: Enrollment, 6 months post-enrollment
Change From Enrollment to 6 Months Post-enrollment in Calcium Levels (mg/dL)
Calcium levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.
Measured: Enrollment, 6 months post-enrollment
Change From Enrollment to 6 Months Post-enrollment in Phosphorous Levels (mg/dL)
Phosphorous levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.
Measured: Enrollment, 6 months post-enrollment
Change From Enrollment to 6 Months Post-enrollment in Calcium-Phosphorous (Ca×P) Product Levels (mg˄2/dL˄2)
Ca×P product levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.
Measured: Enrollment, 6 months post-enrollment
Change From Enrollment to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL)
PTH levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.
Measured: Enrollment, 6 months
Change Per Month From Baseline to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL Per Month)
PTH levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. Linear models based on Generalized Estimating Equations (GEE) were used to assess the effect of time on change from enrollment (at least 1 month after starting treatment with paricalcitol iv) through 3 months post-enrollment and 6 months post-enrollment.
Measured: Enrollment, 3 months post-enrollment, 6 months post-enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Jun 2013

First posted7 Jun 2011 (estimated)
Study startAug 2011
Primary completionJun 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Kidney DiseaseStudies 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
Time perspective: Prospective
Enrolment: 265 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01368042
Sponsor's protocol ID: P12-776
Acronym: QUALITIZE
Status last verified: Jul 2014
First submitted: 6 Jun 2011
Last updated: 1 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Quality of Life in Greek Hemodialysis Patients Receiving Zemplar i.v (QualitiZe)
ClinicalTrials.gov ID: NCT01368042
Acronym / sponsor ID: QUALITIZE / P12-776
Conditions: Chronic Kidney Disease, Secondary Hyperparathyroidism
Keywords: Quality of Life changes, Secondary Hyperparathyroidism, Chronic Kidney Disease, Hemodialysis, Paricalcitol intravenous treatment
Study type: Observational
Recruitment status: Completed
Enrolment: 265 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Aug 2011
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 7 Jun 2011 (estimated)
Results: Posted 24 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Chronic Kidney Disease, Secondary Hyperpathyroidism	–	–All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with chronic kidney disease stage 5 on hemodialysis and diagnosed with secondary hyperparathyroidism, who were prescribed paricalcitol intravenous according to the approved Summary of Product Characteristics

Key inclusion criteria (6 listed)

Patients with chronic kidney disease stage 5 undergoing hemodialysis and receiving paricalcitol iv for more than 1 month.
Patients with a RAND 36-Item Health Survey completed 10 to 35 days before paricalcitol iv initiation
Patients with baseline parathormone ≥ 300 pg/mL
Patients willing to give their informed consent to participate in the study.
Patients should not receive vitamin D-related compounds or cinacalcet for 3 months prior to entering the study

Key exclusion criteria (5 listed)

Patients with a history of clinically significant intolerance or sensitivity to vitamin D or any ingredients of the product.
Patients with persistent hypercalcemia or evidence of vitamin D toxicity.
Patients with a continuous increase in serum (calcium x phosphorus) product greater than 65.
Pregnant or lactating female patients.
Patients who have previously undergone parathyroidectomy

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

Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Physical Functioning' Scale Scores
Time frame: Baseline, 6 months post-enrollment
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including physical functioning. The scores for each scale range from 0 to 100, with 0 representing the worst possible state of physical functioning and 100 representing the best possible state of physical functioning. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Physical Health' Scale Scores
Time frame: Baseline, 6 months post-enrollment
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including role limitations due to physical health. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Emotional Problems' Scale Scores
Time frame: Baseline, 6 months post-enrollment
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including role limitations due to emotional problems. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Energy/Fatigue' Scale Scores
Time frame: Baseline, 6 months post-enrollment
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including energy/fatigue. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Emotional Well-Being' Scale Scores
Time frame: Baseline, 6 months post-enrollment
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including emotional well-being. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Social Functioning' Scale Scores
Time frame: Baseline, 6 months post-enrollment
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including social functioning. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Bodily Pain' Scale Scores
Time frame: Baseline, 6 months post-enrollment
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including bodily pain. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'General Health Perceptions' Scale Scores
Time frame: Baseline, 6 months post-enrollment
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including general health perceptions. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Health Change' Item Scores
Time frame: Baseline, 6 months post-enrollment
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes a single question pertaining to the participant's health change over the last year. The scores range from 0 to 100, with 100: much better than 1 year ago; 75: somewhat better than 1 year ago; 50: about the same; 25: somewhat worse than 1 year ago; 0: much worse than 1 year ago. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey
Time frame: Baseline, enrollment, 3 months post-enrollment, 6 months post-enrollment
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, bodily pain, general health perception, health change). Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the enrollment and post-enrollment visits was calculated as the visit score minus the baseline score. Linear models based on Generalized Estimating Equations (GEE) were used to assess the effect of time on change from baseline through enrollment, 3 months post-enrollment, and 6 months post-enrollment.

7 secondary outcomes

Change From Enrollment to 6 Months Post-enrollment in Urea Levels (mg/dL)
Time frame: Enrollment, 6 months post-enrollment
Change From Enrollment to 6 Months Post-enrollment in Creatinine Levels (mg/dL)
Time frame: Enrollment, 6 months post-enrollment
Change From Enrollment to 6 Months Post-enrollment in Calcium Levels (mg/dL)
Time frame: Enrollment, 6 months post-enrollment
Change From Enrollment to 6 Months Post-enrollment in Phosphorous Levels (mg/dL)
Time frame: Enrollment, 6 months post-enrollment
Change From Enrollment to 6 Months Post-enrollment in Calcium-Phosphorous (Ca×P) Product Levels (mg˄2/dL˄2)
Time frame: Enrollment, 6 months post-enrollment
Change From Enrollment to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL)
Time frame: Enrollment, 6 months
Change Per Month From Baseline to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL Per Month)
Time frame: Enrollment, 3 months post-enrollment, 6 months post-enrollment

Results and safety

Results posted to the registry on 24 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Chronic Kidney Disease, Secondary Hyperpathyroidism	265	235

Primary outcome: Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Physical Functioning' Scale Scores

Time frame: Baseline, 6 months post-enrollment. Mean (Standard Deviation). Unit: scores on a scale

Measure	Chronic Kidney Disease, Secondary Hyperpathyroidism n = 254
Baseline (n=253)	49.3 (30.0)
6 months post-enrollment (n=235)	56.2 (30.4)

Chronic Kidney Disease, Secondary Hyperpathyroidism: Mean Difference (Final Values): 5.7, p = 0.03, Wilcoxon signed rank test-paired samples

Population analysed: All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.

Primary outcome: Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Physical Health' Scale Scores

Time frame: Baseline, 6 months post-enrollment. Mean (Standard Deviation). Unit: scores on a scale

Measure	Chronic Kidney Disease, Secondary Hyperpathyroidism n = 254
Baseline (n=253)	41.5 (43.2)
6 months post-enrollment (n=232)	49.9 (46.4)

Chronic Kidney Disease, Secondary Hyperpathyroidism: Mean Difference (Final Values): 7.3, p = 0.05, Wilcoxon signed rank test-paired samples

Primary outcome: Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Emotional Problems' Scale Scores

Time frame: Baseline, 6 months post-enrollment. Mean (Standard Deviation). Unit: scores on a scale

Measure	Chronic Kidney Disease, Secondary Hyperpathyroidism n = 254
Baseline (n=253)	43.5 (44.4)
6 months post-enrollment (n=232)	54.2 (46.0)

Chronic Kidney Disease, Secondary Hyperpathyroidism: Mean Difference (Final Values): 10.8, p = 0.003, Wilcoxon signed rank test-paired samples

Primary outcome: Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Energy/Fatigue' Scale Scores

Time frame: Baseline, 6 months post-enrollment. Mean (Standard Deviation). Unit: scores on a scale

Measure	Chronic Kidney Disease, Secondary Hyperpathyroidism n = 254
Baseline (n=254)	50.2 (24.8)
6 months post-enrollment (n=235)	63.8 (23.6)

Chronic Kidney Disease, Secondary Hyperpathyroidism: Mean Difference (Final Values): 12.5, p <0.001, Wilcoxon signed rank test-paired samples

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events were collected from enrollment to 30 days after study completion (7 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chronic Kidney Disease, Secondary Hyperpathyroidism	28 of 254 (11%)	0 of 254 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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.

Christos Argyropoulos, MD study chair

AbbVie

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Disease and Secondary Hyperparathyroidism, run by AbbVie (prior sponsor, Abbott) at 11 sites in Greece.

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 6 inclusion and 5 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 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Greece. 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?

Yes. Results are posted in the registry (first posted 24 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Physical Functioning' Scale Scores (time frame: Baseline, 6 months post-enrollment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01368042.

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 1 Aug 2014.