Chronic Kidney Disease 5DNCT06126016
A Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.
An observational study of Chronic Kidney Disease 5D and Secondary Hyperparathyroidism, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Kidney Disease 5D, Secondary Hyperparathyroidism
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Oct 2023to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hemodialysis patients with secondary hyperparathyroidism due to chronic kidney disease(CKD 5D)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
DongGuk university Ilsan hospital
Goyang-si, Gyeonggi-do, 10326
Jangwook Lee
About this study
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
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
- Medical subject headings
- Hyperparathyroidism, Secondary
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D)
Measured: 12 weeks after administration
Secondary outcomes (5)
Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D)
Measured: 24 weeks after administration
Proportion of subjects whose intact parathyroid hormone level decreased by more than 30%
Measured: 12, 24 weeks compared to pre-dose
Incidence of anemia
Measured: From baseline to 12 weeks or 24 weeks
Change in intact parathyroid hormone
Measured: 12, 24 weeks compared to pre-dose
Change in Calcium X Phosphorus
Measured: 12, 24 weeks after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start19 Oct 2023
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease 5DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126016
- Sponsor's protocol ID
- BR-PCT-OS-401
- Status last verified
- Dec 2024
- First submitted
- 6 Nov 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06126016
- Acronym / sponsor ID
- BR-PCT-OS-401
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis patients with secondary hyperparathyroidism due to chronic kidney disease(CKD 5D)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D)
Time frame: 12 weeks after administration
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease 5D and Secondary Hyperparathyroidism, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shinyoung Oh (+82-2-708-8000, syoh@boryung.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D) (time frame: 12 weeks after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.