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

Launched by BORYUNG PHARMACEUTICAL CO., LTD · Nov 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Pacitol Inj. (paricalcitol) to see how well it works and how safe it is for patients with chronic kidney disease who are on hemodialysis and have a condition called secondary hyperparathyroidism. Secondary hyperparathyroidism occurs when the parathyroid glands produce too much hormone due to kidney problems, which can lead to various health issues. The study is currently looking for participants who are hemodialysis patients scheduled to receive this medication.

To be eligible for the trial, participants need to be adults who understand the study and are willing to take part until it finishes. However, certain individuals cannot join, such as those who are allergic to this medication, pregnant or breastfeeding women, or those with specific health issues like vitamin D toxicity or high calcium levels. If you decide to participate, you can expect to receive the medication as part of your regular treatment, and researchers will monitor your health closely throughout the study to gather important information about how well the medication works.

Gender

ALL

Eligibility criteria

• 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.