Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06126016

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chronic Kidney Disease 5D Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Secondary Parathyroid Diseases Secondary Hyperparathyroidism

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

DongGuk university Ilsan hospital

Goyang-si, Gyeonggi-do, 10326, South Korea

Location status: Recruiting

Location contact

Jangwook Lee

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Study contacts

Contact information is provided by the study sponsor or research team.

Shinyoung Oh

CONTACT

[email protected]

+82-2-708-8000

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 13, 2023
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.