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

Sponsor

Boryung Pharmaceutical Co., Ltd (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06126016

Collaborator

(none)

1,000

Enrollment

Location

29.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease 5D Secondary Hyperparathyroidism

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Oct 19, 2023

Anticipated Primary Completion Date :

Apr 1, 2026

Anticipated Study Completion Date :

Apr 1, 2026

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DongGuk university Ilsan hospital	Goyang-si	Gyeonggi-do	Korea, Republic of	10326

Sponsors and Collaborators

Boryung Pharmaceutical Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Boryung Pharmaceutical Co., Ltd

ClinicalTrials.gov Identifier:

NCT06126016

Other Study ID Numbers:

BR-PCT-OS-401

First Posted:

Nov 13, 2023

Last Update Posted:

Nov 13, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasm Metastasis

Kidney Diseases

Renal Insufficiency, Chronic

Hyperparathyroidism

Hyperparathyroidism, Secondary

Study Results

No Results Posted as of Nov 13, 2023