N/A
Completed N=265
Quality of Life in Greek Hemodialysis Patients Receiving Zemplar Intravenous
Source: ClinicalTrials.gov NCT01368042 ↗Enrolled (actual)
265
Serious AEs
11.0%
Results posted
Jul 2014
Primary outcomePrimary: Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Physical Functioning' Scale Scores — 49.3; 56.2 scores on a scale — p=0.03
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Physical Functioning' Scale Scores |
49.3; 56.2 | 0.03 sig |
| PRIMARY Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Physical Health' Scale Scores |
41.5; 49.9 | 0.05 |
| PRIMARY Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Emotional Problems' Scale Scores |
43.5; 54.2 | 0.003 sig |
| PRIMARY Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Energy/Fatigue' Scale Scores |
50.2; 63.8 | <0.001 sig |
| PRIMARY Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Emotional Well-Being' Scale Scores |
59.4; 68.3 | <0.001 sig |
| PRIMARY Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Social Functioning' Scale Scores |
55.9; 67.2 | <0.001 sig |
| PRIMARY Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Bodily Pain' Scale Scores |
57.1; 68.5 | <0.001 sig |
| PRIMARY Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'General Health Perceptions' Scale Scores |
38.9; 39.5 | 0.38 |
| PRIMARY Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Health Change' Item Scores |
50.6; 65.0 | <0.001 sig |
| PRIMARY Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey |
0.67; 1.31; 1.42; 1.34; 0.71; 1.01 | 0.03 sig |
| SECONDARY Change From Enrollment to 6 Months Post-enrollment in Urea Levels (mg/dL) |
147.7; 139.9 | 0.001 sig |
| SECONDARY Change From Enrollment to 6 Months Post-enrollment in Creatinine Levels (mg/dL) |
8.0; 8.3 | 0.03 sig |
| SECONDARY Change From Enrollment to 6 Months Post-enrollment in Calcium Levels (mg/dL) |
9.0; 9.1 | 0.06 |
| SECONDARY Change From Enrollment to 6 Months Post-enrollment in Phosphorous Levels (mg/dL) |
5.2; 5.2 | 0.84 |
| SECONDARY Change From Enrollment to 6 Months Post-enrollment in Calcium-Phosphorous (Ca×P) Product Levels (mg˄2/dL˄2) |
46.6; 47.1 | 0.67 |
| SECONDARY Change From Enrollment to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL) |
423.4; 390.8 | 0.02 sig |
| SECONDARY Change Per Month From Baseline to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL Per Month) |
-5.66 | 0.12 |
Eligibility Criteria
Inclusion Criteria
- Patients with chronic kidney disease stage 5 undergoing hemodialysis and receiving paricalcitol iv for more than 1 month.
- Patients with a RAND 36-Item Health Survey completed 10 to 35 days before paricalcitol iv initiation
- Patients with baseline parathormone ≥ 300 pg/mL
- Patients willing to give their informed consent to participate in the study.
- Patients should not receive vitamin D-related compounds or cinacalcet for 3 months prior to entering the study
- Patients must be on steady regimen for anemia, hypertension and diabetes for the past 30 days
Exclusion Criteria
- Patients with a history of clinically significant intolerance or sensitivity to vitamin D or any ingredients of the product.
- Patients with persistent hypercalcemia or evidence of vitamin D toxicity.
- Patients with a continuous increase in serum (calcium x phosphorus) product greater than 65.
- Pregnant or lactating female patients.
- Patients who have previously undergone parathyroidectomy
Data sourced from ClinicalTrials.gov (NCT01368042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.