Quality of Life in Greek Hemodialysis Patients Receiving Zemplar Intravenous (QUALITIZE)

AbbVie

Status: Completed

Conditions: Chronic Kidney Disease; Secondary Hyperparathyroidism

Study type: Observational

Funder types: Industry

Identifiers

NCT01368042

P12-776

Details and patient eligibility

About

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).

Full 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.

Enrollment: 265 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

265 participants in 1 patient group

Chronic Kidney Disease, Secondary Hyperpathyroidism

Description:

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