NCT06126016Recruiting
A Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.
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
Source: ClinicalTrials.gov · Last updated 12 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 6 Nov 2023
- Start date
- Oct 2023
- Primary completion date
- Apr 2026
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Diseases
- Chronic kidney disease
- NCT number
- NCT06126016
What you commit to
- Study type: Observational
- Planned participants: 1000
- From Oct 2023 to the primary completion date, Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those who have been administered with investigational drugs of other clinical trials within 12 weeks from the baseline(Visit 1).
Other illness
- Those with a history of hypersensitivity reactions to this drug or its components
Other
- 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 are judged by the principle Investigator or sub-Investigator to be ineligible to participate in the study.
Who the study is looking for
- 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.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dongguk University Ilsan Hospital Coordinator of this site? Confirm its status | Goyang-si | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.