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.
Study Type
OBSERVATIONAL
Enrollment
105
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
Percentage of Participants Achieving at Least a 30% Reduction From Baseline in the Levels of Parathyroid Hormone (PTH) at the Final Study Visit
Time frame: Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)
Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24
Hypercalcemia was defined as a value of serum calcium (Ca) greater than or equal to 10.3 mg/dL. Hyperphosphatemia was defined as a value of serum phosphorus (P) greater than or equal to 5.5 mg/dL. Elevated Ca×P was defined as as greater or equal to 56.65 mg\^2/dL\^2, calculated as the result of multiplying the maximum values of calcium (10.3 mg/dL) and phosphorus (5.5 mg/dL).
Time frame: 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
Participants who achieved PTH Levels \< 300 pg/mL between the first and third study visit (Baseline to Week 12) and the third and final study visit (Week 12 to Week 24).
Time frame: 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
Number of participants achieving PTH level reductions to \< 300 pg/mL or 30% below Baseline in 12 weeks (Baseline to Week 12 or Week 12 to Week 24) or in 24 weeks (Baseline to Week 24).
Time frame: 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
The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a visual analogue scale (VAS). For each parameter other than the VAS, participants are asked to indicate which of 5 statements (from 'no problem' to 'extreme problem') best describes their health state.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: 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
The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a VAS. For the VAS portion, health status is assessed by participants on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'worst imaginable health state' (0) and 'best imaginable health state' (100).
Time frame: Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)
Beck Depression Inventory (BDI) Scores At Baseline and Final Study Visit
BDI is a 21-item questionnaire, participant self-report rating inventory that measures characteristic attitudes and symptoms of depression. The range of scores is 0 to 63, with a higher value representing a worse outcome.
Time frame: Baseline Week 1 (Study Visit 1), Week 24 (Final Study Visit)