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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Kidney Disease, Secondary Hyperpathyroidism | All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC) |
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| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Christos Argyropoulos, MD | AbbVie | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 56803 | Arta | 47100 | Greece | |||
| Site Reference ID/Investigator# 53424 |
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| Label | URL |
|---|---|
| Related Info | View source |
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Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chronic Kidney Disease, Secondary Hyperpathyroidism | All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants in the enrolled population, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). 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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Chronic Kidney Disease, Secondary Hyperpathyroidism | All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 6 months post-enrollment |
Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chronic Kidney Disease, Secondary Hyperpathyroidism | All eligible patients treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 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 |
| 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 |
| Athens |
| 11528 |
| Greece |
| Site Reference ID/Investigator# 53425 | Larissa | 41223 | Greece |
| Site Reference ID/Investigator# 56805 | Lefkada | 31100 | Greece |
| Site Reference ID/Investigator# 56802 | MelÃssia | 151 27 | Greece |
| Site Reference ID/Investigator# 66291 | Pátrai | 26225 | Greece |
| Site Reference ID/Investigator# 56809 | Pátrai | 26504 | Greece |
| Site Reference ID/Investigator# 50442 | Pylaia Thessaloniki | 57001 | Greece |
| Site Reference ID/Investigator# 77554 | Thessaloniki | 570 01, | Greece |
| Site Reference ID/Investigator# 77553 | Thessaloniki | 570 19 | Greece |
| Site Reference ID/Investigator# 53422 | Volos | 38221 | Greece |
| Transplanted |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Chronic Kidney Disease, Secondary Hyperpathyroidism | All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC) |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 6 months post-enrollment |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 6 months post-enrollment |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 6 months post-enrollment |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 6 months post-enrollment |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 6 months post-enrollment |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 6 months post-enrollment |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 6 months post-enrollment |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 6 months post-enrollment |
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| Primary | 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. | 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. | Posted | Mean | 95% Confidence Interval | scores on a scale/month | Baseline, enrollment, 3 months post-enrollment, 6 months post-enrollment |
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| Secondary | 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. | All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses. | Posted | Mean | Standard Deviation | mg/dL | Enrollment, 6 months post-enrollment |
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| Secondary | 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. | All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses. | Posted | Mean | Standard Deviation | mg/dL | Enrollment, 6 months post-enrollment |
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| Secondary | 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. | All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses. | Posted | Mean | Standard Deviation | mg/dL | Enrollment, 6 months post-enrollment |
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| Secondary | 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. | All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses. | Posted | Mean | Standard Deviation | mg/dL | Enrollment, 6 months post-enrollment |
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| Secondary | 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. | All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses. | Posted | Mean | Standard Deviation | mg˄2/dL˄2 | Enrollment, 6 months post-enrollment |
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| Secondary | 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. | All enrolled participants with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). | Posted | Mean | Standard Deviation | pg/mL | Enrollment, 6 months |
|
|
|
|
| Secondary | 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. | All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses. | Posted | Mean | 95% Confidence Interval | pg/mL per month | Enrollment, 3 months post-enrollment, 6 months post-enrollment |
|
|
|
|
| 28 |
| 254 |
| 0 |
| 254 |
| Acute myocardial infarction | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Sudden death | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Hematocrit decreased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
|
| Blood parathyroid hormone decreased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
|
| Prothrombin time prolonged | Investigations | MedDRA (16.1) | Non-systematic Assessment |
|
| Red blood cell sedimentation rate increased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Death | General disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Inflammation | General disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Hematochezia | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Large intestinal polyp | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Pancreatic pseudocyst | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Peritoneal hemorrhage | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Ischemic stroke | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Peripheral coldness | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Peripheral ischemia | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Shock | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Vasodilatation | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
| Arteriovenous graft site abscess | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
| Bacteremia | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
|
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
|
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Coma | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Unresponsive to stimuli | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Kidney rupture | Renal and urinary disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Arteriovenous graft | Surgical and medical procedures | MedDRA (16.1) | Non-systematic Assessment |
|
| Nephrectomy | Surgical and medical procedures | MedDRA (16.1) | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Ascites | Hepatobiliary disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Hepatic encephalopathy | Hepatobiliary disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Communication disorder | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Dry gangrene | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
|
| Energy/Fatigue Scale |
|
| Emotional well-being |
|
| Social Functioning Scale |
|
| Bodily Pain Scale |
|
| General Health Perceptions Scale |
|
| Generalized Estimating Equation approach |
Generalized Estimating Equation approach (autoregressive structure) |
| 0.02 |
| No |
| Superiority or Other |
| Role functioning due to emotional problems scale | Generalized Estimating Equation approach | Generalized Estimating Equation approach (autoregressive structure) | 0.01 | No | Superiority or Other |
| Energy/fatigue scale | Generalized Estimating Equation approach | Generalized Estimating Equation approach (autoregressive structure) | <0.001 | No | Superiority or Other |
| Emotional well-being scale | Generalized Estimating Equation approach | Generalized Estimating Equation approach (autoregressive structure) | 0.002 | No | Superiority or Other |
| Social functioning scale | Generalized Estimating Equation approach | Generalized Estimating Equation approach (autoregressive structure) | 0.002 | No | Superiority or Other |
| Bodily pain scale | Generalized Estimating Equation approach | Generalized Estimating Equation approach (autoregressive structure) | <0.001 | No | Superiority or Other |
| General health perceptions scale | Generalized Estimating Equation approach | Generalized Estimating Equation approach (autoregressive structure) | 0.56 | No | Superiority or Other |