Actively Recruiting
A Multi-center, Prospective, Non-interventional, Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj. (Paricalcitol) for Secondary Hyperparathyroidism With Stage 5D Chronic Kidney Disease Receiving Hemodialysis
Led by Boryung Pharmaceutical Co., Ltd · Updated on 2024-12-12
1000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of Pacitol Injection (paricalcitol) in patients with secondary hyperparathyroidism who have stage 5D chronic kidney disease and are receiving hemodialysis. This observational study aims to understand how this medication affects parathyroid hormone levels and other related health measures in this specific patient group. The study is sponsored by Boryung Pharmaceutical Co., Ltd. Participants are hemodialysis patients scheduled to receive Pacitol Injection according to product guidelines. The study observes their response to the medication over time without altering their treatment. The primary measurement is the proportion of subjects whose parathyroid hormone levels meet therapeutic targets 12 weeks after starting the medication. Secondary measurements include hormone levels at 24 weeks, changes in hormone levels compared to before treatment, incidence of anemia, and changes in calcium and phosphorus levels. During the study, participants will be monitored at regular intervals up to 24 weeks to assess hormone levels and other health indicators. Researchers will collect data on safety and efficacy outcomes, including the occurrence of anemia and changes in mineral metabolism. Participants must understand and cooperate with study procedures and complete the study. The study is expected to conclude in April 2026.
CONDITIONS
Brief Title
A Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 years or older
- Hemodialysis patients diagnosed with secondary hyperparathyroidism due to chronic kidney disease stage 5D
- Scheduled to receive Pacitol Injection according to product information
- Able to understand and cooperate with study procedures
- Voluntarily signed consent for personal data collection and study participation
You will not qualify if you...
- History of allergic reactions to Pacitol Injection or its components
- Evidence of vitamin D toxicity
- Hypercalcemia at the time of enrollment
- Pregnant or breastfeeding women
- Diagnosed with parathyroid adenoma planned for parathyroid surgery
- Use of investigational drugs from other clinical trials within 12 weeks before baseline
- Judged by investigators as ineligible to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 weeks after administration
Participants who receive Pacitol Injection as part of their routine care are observed for efficacy and safety outcomes related to secondary hyperparathyroidism.
Visits occur at baseline, 12 weeks, and 24 weeks after administration
Trial Site Locations
Total: 1 location
1
DongGuk university Ilsan hospital
Goyang-si, Gyeonggi-do, South Korea, 10326
Actively Recruiting
Research Team
S
Shinyoung Oh
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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