A Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.
Recruiting · NCT06126016 · Observational (researchers observe without assigning treatment) · Lead sponsor: Boryung Pharmaceutical Co., Ltd
View the official record on ClinicalTrials.gov →What this trial is about
The purpose of this study is to evaluate the efficacy and safety of pacitol Inj.(paricalcitol) for secondary hyperparathyroidism with stage 5D chronic kidney disease (CKD 5D) receiving hemodialysis
Who can take part
Age range
19 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Among hemodialysis patients with secondary hyperparathyroidism due to chronic kidney disease (CKD 5D), those who are scheduled to administer Pacitol Inj. according to the product information.
- Those who voluntarily signed a written personal information collection and usage agreement to participate in this clinical study after receiving an explanation about the objective and methods of the study.
- Those able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion.
Exclusion criteria
- Those with a history of hypersensitivity reactions to this drug or its components
- Those with evidence of vitamin D toxicity
- Those with hypercalcemia at enrollment
- Pregnant or lactating women
- Those with evidence of parathyroid adenoma who is scheduled to undergo parathyroidectomy.
- Those who have been administered with investigational drugs of other clinical trials within 12 weeks from the baseline(Visit 1).
- Those who are judged by the principle Investigator or sub-Investigator to be ineligible to participate in the study.
Where it is running
1 location listed.
- DongGuk university Ilsan hospital - Goyang-si, Gyeonggi-do, South Korea