Status:
RECRUITING
A Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Conditions:
Chronic Kidney Disease 5D
Secondary Hyperparathyroidism
Eligibility:
All Genders
19+ years
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 19 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06126016
Start Date
October 19 2023
End Date
April 1 2026
Last Update
December 12 2024
Active Locations (1)
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1
DongGuk university Ilsan hospital
Goyang-si, Gyeonggi-do, South Korea, 10326