Evaluating the effects of Pacitol Inj. on patients with chronic kidney disease and secondary hyperparathyroidism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the efficacy and safety of Pacitol Inj. (paricalcitol) in patients with stage 5D chronic kidney disease (CKD 5D) who are undergoing hemodialysis and have secondary hyperparathyroidism. Participants will be those scheduled to receive this treatment as per product guidelines, and they will be monitored throughout the study to gather data on the drug's performance. The study will involve voluntary participation with informed consent, ensuring that patients understand the objectives and methods involved.

Why it matters

Who can join: the full rules

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's running

• DongGuk university Ilsan hospital
  Goyang-si, Gyeonggi-do, South Korea Recruiting

Study contacts

• Study coordinator: Shinyoung Oh
• Email: syoh@boryung.co.kr
• Phone: +82-2-708-8000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.