A Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease 5D, Secondary Hyperparathyroidism. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multi-center, Prospective, Non-interventional, Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.(Paricalcitol) for Secondary Hyperparathyroidism With Stage 5D Chronic Kidney Disease (CKD 5D) Receiving Hemodialysis
Overview
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
Primary outcome measures
- Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D) [Time frame: 12 weeks after administration]
Secondary outcome measures (5)
- Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D) [Time frame: 24 weeks after administration]
- Proportion of subjects whose intact parathyroid hormone level decreased by more than 30% [Time frame: 12, 24 weeks compared to pre-dose]
- Incidence of anemia [Time frame: From baseline to 12 weeks or 24 weeks]
- Change in intact parathyroid hormone [Time frame: 12, 24 weeks compared to pre-dose]
- Change in Calcium X Phosphorus [Time frame: 12, 24 weeks after administration]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- DongGuk university Ilsan hospital — Goyang-si
Identifiers
NCT: NCT06126016 · BR-PCT-OS-401