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

Boryung Pharmaceutical Co., Ltd1 site in 1 country1,000 target enrollmentOctober 19, 2023

ConditionsChronic Kidney Disease 5D Secondary Hyperparathyroidism

Overview

Phase: N/A
Intervention: Not specified
Conditions: Chronic Kidney Disease 5D
Sponsor: Boryung Pharmaceutical Co., Ltd
Enrollment: 1000
Locations: 1
Primary Endpoint: Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 19, 2023

End Date

April 2026

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Boryung Pharmaceutical Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: 12 weeks after administration

Secondary Outcomes

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)