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

Recruiting now

Conditions studied: Chronic Kidney Disease 5D, Secondary Hyperparathyroidism

In brief

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

Key facts

Study ID: NCT06126016
Run by: Boryung Pharmaceutical Co., Ltd
People needed: 1000
Starts: 2023-10-19
Expected to finish: 2026-04-01
Last updated by the study team: 2024-12-12

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

DongGuk university Ilsan hospital — Goyang-si, Gyeonggi-do, South Korea (enrolling)

Full record on ClinicalTrials.gov

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