A Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorBoryung Pharmaceutical Co., Ltd
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Hemodialysis patients with secondary hyperparathyroidism due to chronic kidney disease(CKD 5D)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D)
Time frame
12 weeks after administrationSecondary outcomes
1
Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D)
Time frame
24 weeks after administration2
Proportion of subjects whose intact parathyroid hormone level decreased by more than 30%
Time frame
12, 24 weeks compared to pre-dose3
Incidence of anemia
Time frame
From baseline to 12 weeks or 24 weeks4
Change in intact parathyroid hormone
Time frame
12, 24 weeks compared to pre-doseSponsors and contacts
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Source ClinicalTrials.gov