Evaluating the effects of Pacitol Inj. on patients with chronic kidney disease and secondary hyperparathyroidism
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
This study is testing if a new injection called Pacitol can help people with severe kidney disease and high parathyroid hormone levels feel better while they are on dialysis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Boryung Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 1 site (Goyang-si, Gyeonggi-do) |
| Trial ID | NCT06126016 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and safety of Pacitol Inj. (paricalcitol) in patients with stage 5D chronic kidney disease (CKD 5D) who are undergoing hemodialysis and have secondary hyperparathyroidism. Participants will be those scheduled to receive this treatment as per product guidelines, and they will be monitored throughout the study to gather data on the drug's performance. The study will involve voluntary participation with informed consent, ensuring that patients understand the objectives and methods involved.
Who should consider this trial
Good fit: Ideal candidates include hemodialysis patients with secondary hyperparathyroidism due to CKD 5D who are scheduled to receive Pacitol Inj.
Not a fit: Patients with a history of hypersensitivity to the drug, vitamin D toxicity, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for managing secondary hyperparathyroidism in patients with advanced chronic kidney disease.
How similar studies have performed: While this approach has been used in other studies, the specific evaluation of Pacitol Inj. in this patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Goyang-si, Gyeonggi-do
- DongGuk university Ilsan hospital — Goyang-si, Gyeonggi-do, South Korea (Recruiting)
Study contacts
- Study coordinator: Shinyoung Oh
- Email: syoh@boryung.co.kr
- Phone: +82-2-708-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.