Chronic Kidney Disease 5D, Secondary Hyperparathyroidism
Conditions
Brief 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
Interventions
None listed
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D) | 12 weeks after administration |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D) | 24 weeks after administration |
| Proportion of subjects whose intact parathyroid hormone level decreased by more than 30% | 12, 24 weeks compared to pre-dose |
| Incidence of anemia | From baseline to 12 weeks or 24 weeks |
| Change in intact parathyroid hormone | 12, 24 weeks compared to pre-dose |
| Change in Calcium X Phosphorus | 12, 24 weeks after administration |
Countries
South Korea
Contacts
Primary ContactShinyoung Oh
Outcome results
None listed