ClinicalTrials.gg
RecruitingNCT06126016Updated Dec 12, 2024

A Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.

An observational study in Chronic Kidney Disease 5D and Secondary Hyperparathyroidism, sponsored by Boryung Pharmaceutical Co., Ltd. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-12-12.

Sponsored by Boryung Pharmaceutical Co., Ltd · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 3 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
19 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Chronic Kidney Disease 5D
  • Secondary Hyperparathyroidism
03

In context

Hyperparathyroidism, Secondary

188 studies on the registry are indexed under Hyperparathyroidism, Secondary; 15 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 131 across 34 observational studies indexed under Hyperparathyroidism, Secondary.

Browse Hyperparathyroidism, Secondary studies →

Lead sponsor

Boryung Pharmaceutical Co., Ltd is the lead sponsor of 143 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hemodialysis patients with secondary hyperparathyroidism due to chronic kidney disease(CKD 5D)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Those with a history of 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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D)

    Time frame: 12 weeks after administration

Secondary outcomes

  1. Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D)

    Time frame: 24 weeks after administration

  2. Proportion of subjects whose intact parathyroid hormone level decreased by more than 30%

    Time frame: 12, 24 weeks compared to pre-dose

  3. Incidence of anemia

    Time frame: From baseline to 12 weeks or 24 weeks

  4. Change in intact parathyroid hormone

    Time frame: 12, 24 weeks compared to pre-dose

  5. Change in Calcium X Phosphorus

    Time frame: 12, 24 weeks after administration

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2023 (actual). Primary completion is estimated for Apr 2026, 30 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2023
First posted
Nov 13, 2023
StartActual
Oct 19, 2023
Primary completionEst.
Apr 2026
CompletionEst.
Apr 2026
Last update
Dec 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06126016
Responsible party
Sponsor
First posted
Nov 13, 2023
Start date
Oct 19, 2023
Primary completion
Apr 2026 (estimated)
Completion
Apr 2026 (estimated)
Last update
Dec 12, 2024

Study contacts

Shinyoung Oh
Contact
syoh@boryung.co.kr
+82-2-708-8000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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