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

NCT06126016 | Recruiting

• 1 other identifier: BR-PCT-OS-401
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chronic Kidney Disease 5D; Secondary Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

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

  12 weeks after administration

Secondary Outcomes (5)

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

  24 weeks after administration

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

  12, 24 weeks compared to pre-dose

• Incidence of anemia

  From baseline to 12 weeks or 24 weeks

• Change in intact parathyroid hormone

  12, 24 weeks compared to pre-dose

• Change in Calcium X Phosphorus

  12, 24 weeks after administration

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

DongGuk university Ilsan hospital

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

RECRUITING

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Central Study Contacts

Shinyoung Oh

CONTACT

+82-2-708-8000; syoh@boryung.co.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: October 19, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)