NCT06126016 A Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.
| NCT ID | NCT06126016 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boryung Pharmaceutical Co., Ltd |
| Condition | Chronic Kidney Disease 5D |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-10-19 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2023-10-19 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06126016 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Chronic Kidney Disease 5D. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06126016 currently recruiting?
Yes, NCT06126016 is actively recruiting participants. Contact the research team at syoh@boryung.co.kr for enrollment information.
Where is the NCT06126016 trial being conducted?
This trial is being conducted at Goyang-si, South Korea.
Who is sponsoring the NCT06126016 clinical trial?
NCT06126016 is sponsored by Boryung Pharmaceutical Co., Ltd. The trial plans to enroll 1,000 participants.
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