Chronic Kidney Disease, Secondary Hyperparathyroidism
Conditions
Keywords
Quality of Life changes, Secondary Hyperparathyroidism, Chronic Kidney Disease, Hemodialysis, Paricalcitol intravenous treatment
Brief summary
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).
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.
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey | Baseline, enrollment, 3 months post-enrollment, 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 (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. |
| 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. |
| Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Bodily Pain' 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 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 | 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 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 | Baseline, 6 months post-enrollment | 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Enrollment to 6 Months Post-enrollment in Creatinine Levels (mg/dL) | Enrollment, 6 months post-enrollment | 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) | Enrollment, 6 months post-enrollment | 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) | Enrollment, 6 months post-enrollment | 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) | Enrollment, 6 months post-enrollment | 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) | Enrollment, 6 months | 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 Per Month) | Enrollment, 3 months post-enrollment, 6 months post-enrollment | 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. |
| Change From Enrollment to 6 Months Post-enrollment in Urea Levels (mg/dL) | Enrollment, 6 months post-enrollment | 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. |
Countries
Greece
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Chronic Kidney Disease, Secondary Hyperpathyroidism All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC) | 254 |
| Total | 254 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 14 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Protocol Violation | 11 |
| Overall Study | Transplanted | 1 |
Baseline characteristics
| Characteristic | Chronic Kidney Disease, Secondary Hyperpathyroidism |
|---|---|
| Age, Continuous | 67.8 years STANDARD_DEVIATION 12 |
| Sex: Female, Male Female | 95 Participants |
| Sex: Female, Male Male | 159 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 254 |
| serious Total, serious adverse events | 28 / 254 |
Outcome results
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.
Time frame: Baseline, 6 months post-enrollment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Bodily Pain' Scale Scores | Baseline (n=253) | 57.1 scores on a scale | Standard Deviation 28.9 |
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Bodily Pain' Scale Scores | 6 months post-enrollment (n=235) | 68.5 scores on a scale | Standard Deviation 28.5 |
p-value: <0.001Wilcoxon signed rank test-paired samples
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.
Time frame: Baseline, 6 months post-enrollment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Emotional Well-Being' Scale Scores | Baseline (n=254) | 59.4 scores on a scale | Standard Deviation 22 |
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Emotional Well-Being' Scale Scores | 6 months post-enrollment (n=235) | 68.3 scores on a scale | Standard Deviation 22.6 |
p-value: <0.001Wilcoxon signed rank test-paired samples
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.
Time frame: Baseline, 6 months post-enrollment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Energy/Fatigue' Scale Scores | Baseline (n=254) | 50.2 scores on a scale | Standard Deviation 24.8 |
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Energy/Fatigue' Scale Scores | 6 months post-enrollment (n=235) | 63.8 scores on a scale | Standard Deviation 23.6 |
p-value: <0.001Wilcoxon signed rank test-paired samples
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.
Time frame: Baseline, 6 months post-enrollment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'General Health Perceptions' Scale Scores | Baseline (n=254) | 38.9 scores on a scale | Standard Deviation 17.8 |
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'General Health Perceptions' Scale Scores | 6 months post-enrollment (n=235) | 39.5 scores on a scale | Standard Deviation 17.2 |
p-value: 0.38Wilcoxon signed rank test-paired samples
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.
Time frame: Baseline, 6 months post-enrollment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Health Change' Item Scores | Baseline (n=254) | 50.6 scores on a scale | Standard Deviation 26 |
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Health Change' Item Scores | 6 months post-enrollment (n=235) | 65.0 scores on a scale | Standard Deviation 27.1 |
p-value: <0.001Wilcoxon signed rank test-paired samples
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.
Time frame: Baseline, 6 months post-enrollment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Physical Functioning' Scale Scores | Baseline (n=253) | 49.3 scores on a scale | Standard Deviation 30 |
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Physical Functioning' Scale Scores | 6 months post-enrollment (n=235) | 56.2 scores on a scale | Standard Deviation 30.4 |
p-value: 0.03Wilcoxon signed rank test-paired samples
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.
Time frame: Baseline, 6 months post-enrollment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Emotional Problems' Scale Scores | 6 months post-enrollment (n=232) | 54.2 scores on a scale | Standard Deviation 46 |
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Emotional Problems' Scale Scores | Baseline (n=253) | 43.5 scores on a scale | Standard Deviation 44.4 |
p-value: 0.003Wilcoxon signed rank test-paired samples
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.
Time frame: Baseline, 6 months post-enrollment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Physical Health' Scale Scores | Baseline (n=253) | 41.5 scores on a scale | Standard Deviation 43.2 |
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Physical Health' Scale Scores | 6 months post-enrollment (n=232) | 49.9 scores on a scale | Standard Deviation 46.4 |
p-value: 0.05Wilcoxon signed rank test-paired samples
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.
Time frame: Baseline, 6 months post-enrollment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Social Functioning' Scale Scores | Baseline (n=254) | 55.9 scores on a scale | Standard Deviation 28.6 |
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Social Functioning' Scale Scores | 6 months post-enrollment (n=235) | 67.2 scores on a scale | Standard Deviation 28.1 |
p-value: <0.001Wilcoxon signed rank test-paired samples
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.
Time frame: Baseline, enrollment, 3 months post-enrollment, 6 months post-enrollment
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey | Physical Functioning Scale | 0.67 scores on a scale/month |
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey | Role Functioning due to Physical Health Scale | 1.31 scores on a scale/month |
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey | Role Functioning due to Emotional Problems Scale | 1.42 scores on a scale/month |
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey | Energy/Fatigue Scale | 1.34 scores on a scale/month |
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey | Emotional well-being | 0.71 scores on a scale/month |
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey | Social Functioning Scale | 1.01 scores on a scale/month |
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey | Bodily Pain Scale | 1.69 scores on a scale/month |
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey | General Health Perceptions Scale | 0.11 scores on a scale/month |
Comparison: Physical functioning scalep-value: 0.03Generalized Estimating Equation approach
Comparison: Role functioning due to physical health scalep-value: 0.02Generalized Estimating Equation approach
Comparison: Role functioning due to emotional problems scalep-value: 0.01Generalized Estimating Equation approach
Comparison: Energy/fatigue scalep-value: <0.001Generalized Estimating Equation approach
Comparison: Emotional well-being scalep-value: 0.002Generalized Estimating Equation approach
Comparison: Social functioning scalep-value: 0.002Generalized Estimating Equation approach
Comparison: Bodily pain scalep-value: <0.001Generalized Estimating Equation approach
Comparison: General health perceptions scalep-value: 0.56Generalized Estimating Equation approach
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.
Time frame: Enrollment, 6 months
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Enrollment to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL) | Enrollment (n=250) | 423.4 pg/mL | Standard Deviation 331.5 |
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Enrollment to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL) | 6 months post-enrollment (n=218) | 390.8 pg/mL | Standard Deviation 332.6 |
p-value: 0.02Wilcoxon signed rank test-paired samples
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.
Time frame: Enrollment, 6 months post-enrollment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Enrollment to 6 Months Post-enrollment in Calcium Levels (mg/dL) | Enrollment (n=254) | 9.0 mg/dL | Standard Deviation 0.8 |
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Enrollment to 6 Months Post-enrollment in Calcium Levels (mg/dL) | 6 months post-enrollment (n=235) | 9.1 mg/dL | Standard Deviation 0.9 |
p-value: 0.06Wilcoxon signed rank test-paired samples
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.
Time frame: Enrollment, 6 months post-enrollment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Enrollment to 6 Months Post-enrollment in Calcium-Phosphorous (Ca×P) Product Levels (mg˄2/dL˄2) | Enrollment (n=254) | 46.6 mg˄2/dL˄2 | Standard Deviation 14.4 |
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Enrollment to 6 Months Post-enrollment in Calcium-Phosphorous (Ca×P) Product Levels (mg˄2/dL˄2) | 6 months post-enrollment (n=234) | 47.1 mg˄2/dL˄2 | Standard Deviation 14.8 |
p-value: 0.67Wilcoxon signed rank test-paired samples
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.
Time frame: Enrollment, 6 months post-enrollment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Enrollment to 6 Months Post-enrollment in Creatinine Levels (mg/dL) | 6 months post-enrollment (n=235) | 8.3 mg/dL | Standard Deviation 2.8 |
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Enrollment to 6 Months Post-enrollment in Creatinine Levels (mg/dL) | Enrollment (n=254) | 8.0 mg/dL | Standard Deviation 2.7 |
p-value: 0.03Wilcoxon signed rank test-paired samples
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.
Time frame: Enrollment, 6 months post-enrollment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Enrollment to 6 Months Post-enrollment in Phosphorous Levels (mg/dL) | Enrollment (n=254) | 5.2 mg/dL | Standard Deviation 1.4 |
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Enrollment to 6 Months Post-enrollment in Phosphorous Levels (mg/dL) | 6 months post-enrollment (n=234) | 5.2 mg/dL | Standard Deviation 1.5 |
p-value: 0.84Wilcoxon signed rank test-paired samples
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.
Time frame: Enrollment, 6 months post-enrollment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Enrollment to 6 Months Post-enrollment in Urea Levels (mg/dL) | Enrollment (n=254) | 147.7 mg/dL | Standard Deviation 42.3 |
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change From Enrollment to 6 Months Post-enrollment in Urea Levels (mg/dL) | 6 month post-enrollment (n=235) | 139.9 mg/dL | Standard Deviation 43.1 |
p-value: 0.001Wilcoxon signed rank test-paired samples
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.
Time frame: Enrollment, 3 months post-enrollment, 6 months post-enrollment
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Chronic Kidney Disease, Secondary Hyperpathyroidism | Change Per Month From Baseline to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL Per Month) | -5.66 pg/mL per month |
p-value: 0.12Generalized Estimating Equation approach