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

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

NCT ID: NCT06126016

Condition: Chronic Kidney Disease 5D
Secondary Hyperparathyroidism

Conditions: Official terms:
Neoplasm Metastasis
Kidney Diseases
Renal Insufficiency, Chronic
Hyperparathyroidism
Hyperparathyroidism, Secondary

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

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

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
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.

Gender: All

Minimum age: 19 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: DongGuk university Ilsan hospital

Address:
City: Goyang-si
Zip: 10326
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Jangwook Lee

Start date: October 19, 2023

Completion date: April 2026

Lead sponsor:
Agency: Boryung Pharmaceutical Co., Ltd
Agency class: Industry

Source: Boryung Pharmaceutical Co., Ltd

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06126016