Post Marketing Observational Study on Paricalcitol IV Administered to Venezuelan Patients

NCT ID: NCT01758289

Last Updated: 2014-11-17

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 105 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-11-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeanine Obage, MD

Role: STUDY_CHAIR

Abbott

Locations

Site Reference ID/Investigator# 96757

Acarigua, , Venezuela

Site Reference ID/Investigator# 96766

Barquisimeto, , Venezuela

Site Reference ID/Investigator# 96768

Caracas, , Venezuela

Site Reference ID/Investigator# 96760

Maracaibo, , Venezuela

Site Reference ID/Investigator# 96761

Maracaibo, , Venezuela

Site Reference ID/Investigator# 96770

Miranda, , Venezuela

Site Reference ID/Investigator# 96763

Monagas, , Venezuela

Site Reference ID/Investigator# 96765

Naguanagua, , Venezuela

Countries

Venezuela

Other Identifiers

P13-785

Identifier Type: -

Identifier Source: org_study_id