Quality of Life in Greek Hemodialysis Patients Receiving Zemplar Intravenous (QUALITIZE)
This study is ongoing, but not recruiting participants.
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01368042
First received: June 6, 2011
Last updated: April 12, 2013
Last verified: April 2013
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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 Intravenous (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
| Estimated Enrollment: | 265 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated 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:
- Patients with Chronic Kidney Disease stage 5 undergoing haemodialysis and receiving Zemplar for more than 1 month.
- Patients with a Kidney Disease Quality Of Life Short Form 36 filled 10-35 days before Zemplar initiation
- Patients with baseline parathormone ≥ 300 pg/mL
- Patients (male and female) ≥ 18 years of age.
- 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 hypercalcaemia or evidence of Vitamin D toxicity.
- Patients with a continuous increase of calcium x phosphorus plasma sum, greater than 65.
- Pregnant or lactating female patients.
- 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: | April 12, 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 May 23, 2013