Clinical trial NCT01368042: Quality of Life in Greek Hemodialysis Patients Receiving Zemplar Intravenous
Official title: Quality of Life in Greek Hemodialysis Patients Receiving Zemplar i.v (QualitiZe)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Secondary Hyperparathyroidism
Keywords: Quality of Life changes
Secondary Hyperparathyroidism
Chronic Kidney Disease
Hemodialysis
Paricalcitol intravenous treatment
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Physical Functioning' Scale Scores
timeFrame: Baseline, 6 months post-enrollment
measure: Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Physical Health' Scale Scores
timeFrame: Baseline, 6 months post-enrollment
measure: Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Emotional Problems' Scale Scores
timeFrame: Baseline, 6 months post-enrollment
measure: Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Energy/Fatigue' Scale Scores
timeFrame: Baseline, 6 months post-enrollment
measure: Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Emotional Well-Being' Scale Scores
timeFrame: Baseline, 6 months post-enrollment
measure: Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Social Functioning' Scale Scores
timeFrame: Baseline, 6 months post-enrollment
measure: Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Bodily Pain' Scale Scores
timeFrame: Baseline, 6 months post-enrollment
measure: Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'General Health Perceptions' Scale Scores
timeFrame: Baseline, 6 months post-enrollment
measure: Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Health Change' Item Scores
timeFrame: Baseline, 6 months post-enrollment
measure: Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey
timeFrame: Baseline, enrollment, 3 months post-enrollment, 6 months post-enrollment
Secondary outcomes:
measure: Change From Enrollment to 6 Months Post-enrollment in Urea Levels (mg/dL)
timeFrame: Enrollment, 6 months post-enrollment
measure: Change From Enrollment to 6 Months Post-enrollment in Creatinine Levels (mg/dL)
timeFrame: Enrollment, 6 months post-enrollment
measure: Change From Enrollment to 6 Months Post-enrollment in Calcium Levels (mg/dL)
timeFrame: Enrollment, 6 months post-enrollment
measure: Change From Enrollment to 6 Months Post-enrollment in Phosphorous Levels (mg/dL)
timeFrame: Enrollment, 6 months post-enrollment
measure: Change From Enrollment to 6 Months Post-enrollment in Calcium-Phosphorous (Ca×P) Product Levels (mg˄2/dL˄2)
timeFrame: Enrollment, 6 months post-enrollment
measure: Change From Enrollment to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL)
timeFrame: Enrollment, 6 months
measure: Change Per Month From Baseline to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL Per Month)
timeFrame: Enrollment, 3 months post-enrollment, 6 months post-enrollment
Other outcomes:
Locations:
city: Arta
country: Greece
facility: Site Reference ID/Investigator# 56803
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 53424
city: Larissa
country: Greece
facility: Site Reference ID/Investigator# 53425
city: Lefkada
country: Greece
facility: Site Reference ID/Investigator# 56805
city: Melissia
country: Greece
facility: Site Reference ID/Investigator# 56802
city: Patras
country: Greece
facility: Site Reference ID/Investigator# 66291
city: Patras
country: Greece
facility: Site Reference ID/Investigator# 56809
city: Pylaia Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 50442
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 77554
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 77553
city: Volos
country: Greece
facility: Site Reference ID/Investigator# 53422
Study officials:
affiliation: AbbVie
name: Christos Argyropoulos, MD
role: STUDY_CHAIR
References: