Quality of Life in Greek Hemodialysis Patients Receiving Zemplar Intravenous (QUALITIZE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01368042
First received: June 6, 2011
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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).


Condition
Chronic Kidney Disease
Secondary Hyperparathyroidism

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Quality of Life in Greek Hemodialysis Patients Receiving Zemplar i.v (QualitiZe)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Enrollment to 6 Months Post-enrollment in Urea Levels (mg/dL) [ Time Frame: Enrollment, 6 months post-enrollment ] [ Designated as safety issue: Yes ]
    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.

  • Change From Enrollment to 6 Months Post-enrollment in Creatinine Levels (mg/dL) [ Time Frame: Enrollment, 6 months post-enrollment ] [ Designated as safety issue: Yes ]
    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.

  • Change From Enrollment to 6 Months Post-enrollment in Calcium Levels (mg/dL) [ Time Frame: Enrollment, 6 months post-enrollment ] [ Designated as safety issue: Yes ]
    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.

  • Change From Enrollment to 6 Months Post-enrollment in Phosphorous Levels (mg/dL) [ Time Frame: Enrollment, 6 months post-enrollment ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Change From Enrollment to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL) [ Time Frame: Enrollment, 6 months ] [ Designated as safety issue: No ]
    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.

  • Change Per Month From Baseline to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL) [ Time Frame: Enrollment, 3 months post-enrollment, 6 months post-enrollment ] [ Designated as safety issue: No ]
    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.


Enrollment: 265
Study Start Date: August 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chronic Kidney Disease, Secondary Hyperpathyroidism
All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with a history of clinically significant intolerance or sensitivity to vitamin D or any ingredients of the product.
  2. Patients with persistent hypercalcemia or evidence of vitamin D toxicity.
  3. Patients with a continuous increase in serum (calcium x phosphorus) product greater than 65.
  4. Pregnant or lactating female patients.
  5. Patients who have previously undergone parathyroidectomy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368042

Locations
Greece
Site Reference ID/Investigator# 56803
Arta, Greece, 47100
Site Reference ID/Investigator# 53424
Athens, Greece, 11528
Site Reference ID/Investigator# 53425
Larissa, Greece, 41223
Site Reference ID/Investigator# 56805
Lefkada, Greece, 31100
Site Reference ID/Investigator# 56802
Melissia, Greece, 151 27
Site Reference ID/Investigator# 66291
Patras, Greece, 26225
Site Reference ID/Investigator# 56809
Patras, Greece, 26504
Site Reference ID/Investigator# 50442
Pylaia Thessaloniki, Greece, 57001
Site Reference ID/Investigator# 77554
Thessaloniki, Greece, 570 01,
Site Reference ID/Investigator# 77553
Thessaloniki, Greece, 570 19
Site Reference ID/Investigator# 53422
Volos, Greece, 38221
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Chair: Christos Argyropoulos, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01368042     History of Changes
Other Study ID Numbers: P12-776
Study First Received: June 6, 2011
Results First Received: June 26, 2014
Last Updated: June 26, 2014
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by AbbVie:
Quality of Life changes
Secondary Hyperparathyroidism
Chronic Kidney Disease
Hemodialysis
Paricalcitol intravenous treatment

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 26, 2014