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

Recruiting

• Conditions: Chronic Kidney Disease 5D; Secondary Hyperparathyroidism

• Registration Number: NCT06126016
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-19
• Study First Submitted: 2023-11-06
• Study First Submitted QC: 2023-11-06
• Study First Posted: 2023-11-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-12
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D)	12 weeks after administration

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

DongGuk university Ilsan hospital; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of