Clinical trial NCT01758289: Post Marketing Observational Study on Paricalcitol IV Administered to Venezuelan Patients
Official title: A Prospective, Multicenter, Six-Month Study on the Effectiveness, Safety and Impact on Health Related Quality of Life (HRQoL) and Depression Symptoms of Paricalcitol Administered to Venezuelan Patients With Chronic Kidney Disease (Stage V) Who Are on Hemodialysis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Kidney Disease Stage V
Hemodialysis
Keywords: Venezuelan Patients
Depressive Symptoms
Health Related Quality of Life
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2013-01-01
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study was conducted in 8 hemodialysis units distributed in Venezuela.

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.


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

Primary outcomes:
measure: Percentage of Participants Achieving at Least a 30% Reduction From Baseline in the Levels of Parathyroid Hormone (PTH) at the Final Study Visit
timeFrame: Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)
Secondary outcomes:
measure: Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24
timeFrame: Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)
measure: Number of Participants Achieving Parathyroid Hormone (PTH) Levels < 300 pg/mL
timeFrame: Baseline to Week 12, Week 12 to Week 24
measure: Number of Participants Achieving PTH Level Reductions to < 300 pg/mL or 30% Below Baseline in 12 or 24 Weeks
timeFrame: Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)
measure: 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
timeFrame: Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)
measure: European Quality of Life 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Scores At Baseline, Week 12, and Week 24
timeFrame: Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)
measure: Beck Depression Inventory (BDI) Scores At Baseline and Final Study Visit
timeFrame: Baseline Week 1 (Study Visit 1), Week 24 (Final Study Visit)
Other outcomes:
Locations:
city: Acarigua
country: Venezuela
facility: Site Reference ID/Investigator# 96757
city: Barquisimeto
country: Venezuela
facility: Site Reference ID/Investigator# 96766
city: Caracas
country: Venezuela
facility: Site Reference ID/Investigator# 96768
city: Maracaibo
country: Venezuela
facility: Site Reference ID/Investigator# 96760
city: Maracaibo
country: Venezuela
facility: Site Reference ID/Investigator# 96761
city: Miranda
country: Venezuela
facility: Site Reference ID/Investigator# 96770
city: Monagas
country: Venezuela
facility: Site Reference ID/Investigator# 96763
city: Naguanagua
country: Venezuela
facility: Site Reference ID/Investigator# 96765
Study officials:
affiliation: Abbott
name: Jeanine Obage, MD
role: STUDY_CHAIR
References: