Quality of Life in Greek Hemodialysis Patients Receiving Zemplar Intravenous

NCT01368042 | Completed Results

• 1 other identifier: P12-776
• Study Type: observational
• Target: 265
• Locations: 1 country
• Sites: 11

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).

Conditions

Chronic Kidney Disease; Secondary Hyperparathyroidism

Keywords

Quality of Life changes; Secondary Hyperparathyroidism; Chronic Kidney Disease; Hemodialysis; Paricalcitol intravenous treatment

Outcome Measures

Primary Outcomes (10)

• Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Physical Functioning' Scale Scores

  The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including physical functioning. The scores for each scale range from 0 to 100, with 0 representing the worst possible state of physical functioning and 100 representing the best possible state of physical functioning. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.

  Baseline, 6 months post-enrollment

• Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Physical Health' Scale Scores

  The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including role limitations due to physical health. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.

  Baseline, 6 months post-enrollment

• Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Emotional Problems' Scale Scores

  The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including role limitations due to emotional problems. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.

  Baseline, 6 months post-enrollment

• Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Energy/Fatigue' Scale Scores

  The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including energy/fatigue. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.

  Baseline, 6 months post-enrollment

• Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Emotional Well-Being' Scale Scores

  The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including emotional well-being. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.

  Baseline, 6 months post-enrollment

• Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Social Functioning' Scale Scores

  The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including social functioning. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.

  Baseline, 6 months post-enrollment

• Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Bodily Pain' Scale Scores

  The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including bodily pain. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.

  Baseline, 6 months post-enrollment

• Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'General Health Perceptions' Scale Scores

  The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including general health perceptions. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.

  Baseline, 6 months post-enrollment

• Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Health Change' Item Scores

  The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes a single question pertaining to the participant's health change over the last year. The scores range from 0 to 100, with 100: much better than 1 year ago; 75: somewhat better than 1 year ago; 50: about the same; 25: somewhat worse than 1 year ago; 0: much worse than 1 year ago. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.

  Baseline, 6 months post-enrollment

• Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey

  The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, bodily pain, general health perception, health change). Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the enrollment and post-enrollment visits was calculated as the visit score minus the baseline score. Linear models based on Generalized Estimating Equations (GEE) were used to assess the effect of time on change from baseline through enrollment, 3 months post-enrollment, and 6 months post-enrollment.

  Baseline, enrollment, 3 months post-enrollment, 6 months post-enrollment

Secondary Outcomes (7)

• Change From Enrollment to 6 Months Post-enrollment in Urea Levels (mg/dL)

  Enrollment, 6 months post-enrollment

• Change From Enrollment to 6 Months Post-enrollment in Creatinine Levels (mg/dL)

  Enrollment, 6 months post-enrollment

• Change From Enrollment to 6 Months Post-enrollment in Calcium Levels (mg/dL)

  Enrollment, 6 months post-enrollment

• Change From Enrollment to 6 Months Post-enrollment in Phosphorous Levels (mg/dL)

  Enrollment, 6 months post-enrollment

• Change From Enrollment to 6 Months Post-enrollment in Calcium-Phosphorous (Ca×P) Product Levels (mg˄2/dL˄2)

  Enrollment, 6 months post-enrollment

Study Arms (1)

Chronic Kidney Disease, Secondary Hyperpathyroidism

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients with chronic kidney disease stage 5 undergoing hemodialysis and receiving paricalcitol iv for more than 1 month.
• Patients with a RAND 36-Item Health Survey completed 10 to 35 days before paricalcitol iv initiation
• Patients with baseline parathormone ≥ 300 pg/mL
• 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

You may not qualify if:

• Patients with a history of clinically significant intolerance or sensitivity to vitamin D or any ingredients of the product.
• Patients with persistent hypercalcemia or evidence of vitamin D toxicity.
• Patients with a continuous increase in serum (calcium x phosphorus) product greater than 65.
• Pregnant or lactating female patients.
• Patients who have previously undergone parathyroidectomy

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (11)

Site Reference ID/Investigator# 56803

Arta, 47100, Greece

Location

Site Reference ID/Investigator# 53424

Athens, 11528, Greece

Location

Site Reference ID/Investigator# 53425

Larissa, 41223, Greece

Location

Site Reference ID/Investigator# 56805

Lefkada, 31100, Greece

Location

Site Reference ID/Investigator# 56802

Melíssia, 151 27, Greece

Location

Site Reference ID/Investigator# 66291

Pátrai, 26225, Greece

Location

Site Reference ID/Investigator# 56809

Pátrai, 26504, Greece

Location

Site Reference ID/Investigator# 50442

Pylaia Thessaloniki, 57001, Greece

Location

Site Reference ID/Investigator# 77554

Thessaloniki, 570 01,, Greece

Location

Site Reference ID/Investigator# 77553

Thessaloniki, 570 19, Greece

Location

Site Reference ID/Investigator# 53422

Volos, 38221, Greece

Location

Related Links

• Related Info

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperparathyroidism, Secondary

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Christos Argyropoulos, MD

  AbbVie

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 7, 2011
• Study Start: August 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 1, 2014
• Results First Posted: July 24, 2014

Record last verified: 2014-07

Locations

GR (11)