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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-19

Study Completion Date

2026-04-30

Brief Summary

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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

Detailed Description

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Conditions

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Chronic Kidney Disease 5D Secondary Hyperparathyroidism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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DongGuk university Ilsan hospital

Goyang-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Shinyoung Oh

Role: CONTACT

Phone: +82-2-708-8000

Email: [email protected]

Facility Contacts

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Jangwook Lee

Role: primary

Other Identifiers

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BR-PCT-OS-401

Identifier Type: -

Identifier Source: org_study_id