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).
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
265
Site Reference ID/Investigator# 56803
Arta, Greece
Site Reference ID/Investigator# 53424
Athens, Greece
Site Reference ID/Investigator# 53425
Larissa, Greece
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.
Time frame: 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.
Time frame: 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.
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Site Reference ID/Investigator# 56805
Lefkada, Greece
Site Reference ID/Investigator# 56802
Melíssia, Greece
Site Reference ID/Investigator# 66291
Pátrai, Greece
Site Reference ID/Investigator# 56809
Pátrai, Greece
Site Reference ID/Investigator# 50442
Pylaia Thessaloniki, Greece
Site Reference ID/Investigator# 77554
Thessaloniki, Greece
Site Reference ID/Investigator# 77553
Thessaloniki, Greece
...and 1 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, enrollment, 3 months post-enrollment, 6 months post-enrollment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: Enrollment, 3 months post-enrollment, 6 months post-enrollment