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

December 10, 2024 updated by: Boryung Pharmaceutical Co., Ltd

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Shinyoung Oh
Phone Number: +82-2-708-8000
Email: syoh@boryung.co.kr

Study Locations

Korea, Republic of
- Gyeonggi-do
  - Goyang-si, Gyeonggi-do, Korea, Republic of, 10326
    - Recruiting
    - Dongguk University Ilsan Hospital
    - Contact:
      
      Jangwook Lee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D) Time Frame: 12 weeks after administration	12 weeks after administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D) Time Frame: 24 weeks after administration	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	12, 24 weeks compared to pre-dose
Incidence of anemia Time Frame: From baseline to 12 weeks or 24 weeks	From baseline to 12 weeks or 24 weeks
Change in intact parathyroid hormone Time Frame: 12, 24 weeks compared to pre-dose	12, 24 weeks compared to pre-dose
Change in Calcium X Phosphorus Time Frame: 12, 24 weeks after administration	12, 24 weeks after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boryung Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2023

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

November 6, 2023

First Submitted That Met QC Criteria