Post Marketing Observational Study on Paricalcitol IV Administered to Venezuelan Patients

NCT01758289 | Terminated Results

• 1 other identifier: P13-785
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 8

Brief Summary

This study was designed to evaluate the effectiveness, safety, and impact on quality of life when paricalcitol (Zemplar® intravenous \[IV\]) is administered in Venezuelan patients on hemodialysis who are at risk of developing secondary hyperparathyroidism associated with stage V chronic kidney disease.

Conditions

Chronic Kidney Disease Stage V; Hemodialysis

Keywords

Venezuelan Patients; Depressive Symptoms; Health Related Quality of Life

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving at Least a 30% Reduction From Baseline in the Levels of Parathyroid Hormone (PTH) at the Final Study Visit

  Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)

Secondary Outcomes (6)

• Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24

  Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)

• Number of Participants Achieving Parathyroid Hormone (PTH) Levels < 300 pg/mL

  Baseline to Week 12, Week 12 to Week 24

• Number of Participants Achieving PTH Level Reductions to < 300 pg/mL or 30% Below Baseline in 12 or 24 Weeks

  Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)

• European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24

  Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)

• European Quality of Life 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Scores At Baseline, Week 12, and Week 24

  Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)

Study Arms (1)

Paricalcitol IV

Eligible participants with diagnosis of chronic kidney disease stage V undergoing hemodialysis, treated with paricalcitol IV per routine clinical practice according to prescribing information approved in Venezuela and clinical criteria.

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

This study was conducted in 8 hemodialysis units distributed in Venezuela.

You may qualify if:

• Male or female ≥ 18 years old with documented diagnosis of stage V chronic kidney disease, on hemodialysis at study baseline
• Subjects who have been previously treated with vitamin D or its metabolites or naïve to paricalcitol
• Subjects in whom the use of paricalcitol is clinically indicated and documented by applicable and routine standard of healthcare (i.e. laboratory assessments and clinical evaluations) according to the criteria of the attending physician and in accordance with the approved label of the product in Venezuela
• Subjects that provide written informed consent form stating his/her authorization and willingness to participate in the study and allowing the use and discussion of his/her personal and/or health information before entering the study
• Female subjects with reproductive potential must use an approved contraceptive method (intrauterine device, birth control pills or barrier device) during and for three (03) months after discontinuation of treatment

You may not qualify if:

• Subjects with severe hyperparathyroidism (parathyroid hormone \[PTH\] \> 3000 pg/mL)
• Subjects with hypercalcemia, adjusted according to serum albumin, hyperphosphatemia, or subjects with calcium-phosphorus product (Ca x P) ≥ 70
• Known hypersensitivity and/or toxicity of vitamin D, its metabolites and/or other components of Zemplar® IV (paricalcitol)
• Subjects who have participated in clinical trials within 30 days before the start of the study or who are currently enrolled in a clinical trial or under treatment with any investigational product
• Subjects who cannot tolerate or cannot take phosphate binders that do not contain calcium and/or aluminum
• Subjects who in the opinion of the investigator, for any reason (including medical reasons) are not eligible and/or appropriate for therapy with synthetic analogs of vitamin D and/or unwilling to complete the study visits

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (8)

Site Reference ID/Investigator# 96757

Acarigua, Venezuela

Location

Site Reference ID/Investigator# 96766

Barquisimeto, Venezuela

Location

Site Reference ID/Investigator# 96768

Caracas, Venezuela

Location

Site Reference ID/Investigator# 96760

Maracaibo, Venezuela

Location

Site Reference ID/Investigator# 96761

Maracaibo, Venezuela

Location

Site Reference ID/Investigator# 96770

Miranda, Venezuela

Location

Site Reference ID/Investigator# 96763

Monagas, Venezuela

Location

Site Reference ID/Investigator# 96765

Naguanagua, Venezuela

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

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

800-633-9110

Study Officials

• Jeanine Obage, MD

  Abbott

  STUDY CHAIR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: December 27, 2012
• First Posted: January 1, 2013
• Study Start: January 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 17, 2014
• Results First Posted: November 17, 2014

Record last verified: 2014-11

Locations

VE (8)