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

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

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).

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease; Secondary Hyperparathyroidism

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.

• Study Type: Observational
• Enrollment (Actual): 265

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Chronic Kidney Disease, Secondary Hyperpathyroidism; All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline, enrollment, 3 months post-enrollment, 6 months post-enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	Enrollment, 3 months post-enrollment, 6 months post-enrollment

Collaborators and Investigators

• Sponsor: AbbVie (prior sponsor, Abbott)
• Investigators: Study Chair: Christos Argyropoulos, MD, AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: June 6, 2011
• First Submitted That Met QC Criteria: June 6, 2011
• First Posted (Estimate): June 7, 2011

Study Record Updates

• Last Update Posted (Estimate): August 1, 2014
• Last Update Submitted That Met QC Criteria: July 29, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; Hemodialysis; Secondary Hyperparathyroidism; Quality of Life changes; Paricalcitol intravenous treatment
• Additional Relevant MeSH Terms: Urologic Diseases; Endocrine System Diseases; Renal Insufficiency; Parathyroid Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
• Other Study ID Numbers: P12-776