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Quality of Life in Greek Hemodialysis Patients Receiving Zemplar i.v (QualitiZe) (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).
Details
| Lead sponsor | AbbVie (prior sponsor, Abbott) |
|---|---|
| Status | COMPLETED |
| Enrolment | 265 |
| Start date | 2011-08 |
| Completion | 2013-06 |
Conditions
- Chronic Kidney Disease
- Secondary Hyperparathyroidism
Primary outcomes
- Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Physical Functioning' Scale Scores — 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 — 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 — 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 — 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 — 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 — 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.
Countries
Greece