RecruitingNCT06126016

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

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 (CKD 5D) Receiving Hemodialysis

Sponsor

Boryung Pharmaceutical Co., Ltd

Enrollment

1,000 participants

Start Date

Oct 19, 2023

Study Type

OBSERVATIONAL

Conditions

Chronic Kidney Disease 5D Secondary Hyperparathyroidism

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

Min Age: 19 Years

Inclusion Criteria3

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 Criteria7

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.