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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01368042
First received: June 6, 2011
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to assess Quality of Life changes on Chronic Kidney Disease patients with secondary hyperparathyroidism undergoing haemodialysis and receiving Paricalcitol intravenous


Condition
Chronic Kidney Disease
Secondary Hyperparathyroidism

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Quality of Life in Greek Hemodialysis Patients Receiving Zemplar i.v (QualitiZe)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Change of mean values in the different categories of the quality of life questionnaire Kidney Disease Quality Of Life Short Form 36 in hemodialysis patients with secondary hyperparathyroidism that receive Paricalcitol [ Time Frame: Every three months up to 6 months ] [ Designated as safety issue: No ]
    Change of mean values in the different categories of the quality of life questionnaire Kidney Disease Quality Of Life Short Form 36 in hemodialysis patients with secondary hyperparathyroidism that receive Paricalcitol


Enrollment: 265
Study Start Date: July 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chronic Kidney Disease, secondary hyperpathyroidism
All eligible patients treated with Paricalcitol intravenous according to the approved Summary of Product Characteristics

Detailed Description:

The scientific purpose of this study is to obtain data on the use of Zemplar intravenous in real-life clinical practice and the effect it has on patients' quality of life. In this study, Zemplar will be prescribed on an on-label basis in an everyday setting. Quality of life questionnaire (Kidney Disease Quality Of Life Short Form 36) results will be collected for a 6 month period (every three months) in order to assess Zemplar's effect on patient's quality of life.

The primary aim of the study is to assess Quality of Life changes on Chronic Kidney Disease patients with secondary parathyroidism undergoing haemodialysis and receiving Paricalcitol intravenous.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  1. Patients with Chronic Kidney Disease stage 5 undergoing haemodialysis and receiving Zemplar for more than 1 month.
  2. Patients with a Kidney Disease Quality Of Life Short Form 36 filled 10-35 days before Zemplar initiation
  3. Patients with baseline parathormone ≥ 300 pg/mL
  4. Patients (male and female) ≥ 18 years of age.
  5. Patients willing to give their informed consent to participate in the study.
  6. Patients should not receive Vitamin D-related compounds or Cinacalcet for 3 months prior to entering the study
  7. 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 hypercalcaemia or evidence of Vitamin D toxicity.
  3. Patients with a continuous increase of calcium x phosphorus plasma sum, greater than 65.
  4. Pregnant or lactating female patients.
  5. Patients who have previously undergone parathyroidectomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368042

Locations
Greece
Site Reference ID/Investigator# 56803
Arta, Greece, 47100
Site Reference ID/Investigator# 53424
Athens, Greece, 11528
Site Reference ID/Investigator# 53425
Larissa, Greece, 41223
Site Reference ID/Investigator# 56805
Lefkada, Greece, 31100
Site Reference ID/Investigator# 56802
Melissia, Greece, 151 27
Site Reference ID/Investigator# 66291
Patras, Greece, 26225
Site Reference ID/Investigator# 56809
Patras, Greece, 26504
Site Reference ID/Investigator# 50442
Pylaia Thessaloniki, Greece, 57001
Site Reference ID/Investigator# 77554
Thessaloniki, Greece, 570 01,
Site Reference ID/Investigator# 77553
Thessaloniki, Greece, 570 19
Site Reference ID/Investigator# 53422
Volos, Greece, 38221
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Chair: Christos Argyropoulos, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01368042     History of Changes
Other Study ID Numbers: P12-776
Study First Received: June 6, 2011
Last Updated: July 1, 2013
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by AbbVie:
Quality of Life changes
Secondary Hyperparathyroidism
Chronic Kidney Disease
Hemodialysis
Paricalcitol intravenous treatment

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on April 16, 2014