Quality of Life in Greek Hemodialysis Patients Receiving Zemplar Intravenous

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

265 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-06-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Chronic Kidney Disease Secondary Hyperparathyroidism

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic Kidney Disease, Secondary Hyperpathyroidism

All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No