Observational Study of Pacitol Injection for Safety and Effectiveness in Adults with Secondary Hyperparathyroidism and Stage 5D Chronic Kidney Disease on Hemodialysis

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.

A Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.