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

Secondary Hyperparathyroidism Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06126016
• Other study ID #: BR-PCT-OS-401
• Status: Recruiting
• Start date: October 19, 2023
• Est. completion date: April 2026

Study information

• Verified date: December 2023
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: Shinyoung Oh
• Phone: +82-2-708-8000
• Email: syoh[@]boryung.co.kr
• Is FDA regulated: No
• Study type: Observational

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease 5D
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Neoplasm Metastasis
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

Locations

Country	Name	City	State
Korea, Republic of	DongGuk university Ilsan hospital	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D)		12 weeks after administration
Secondary	Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D)		24 weeks after administration
Secondary	Proportion of subjects whose intact parathyroid hormone level decreased by more than 30%		12, 24 weeks compared to pre-dose
Secondary	Incidence of anemia		From baseline to 12 weeks or 24 weeks
Secondary	Change in intact parathyroid hormone		12, 24 weeks compared to pre-dose
Secondary	Change in Calcium X Phosphorus		12, 24 weeks after administration