Neutrophil Gelatinase-associated Lipocalin VS Vascular Calcification in Maintenance Hemodialysis Patients
NCT ID: NCT05720273
Last Updated: 2024-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
80 participants
INTERVENTIONAL
2023-04-01
2025-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of 1.25 mmol/L Calcium Dialysate on Mineral Metabolism in Haemodialysis Patients.
NCT00744302
the Effect of Calcium Dobesilate on Non Dialysis Patients With CKD
NCT03427944
Low Protein Diet Supplemented With Ketoanalogs on Reducing Proteinuria and Maintaining Nutritional Status in Type 2 Diabetic Nephropathy
NCT01300273
Cincalcet and Vascular Arterial Stiffness Among Peritoneal Dialysis Patients With Secondary Hyperparathyroidism
NCT01143987
Controlled Study to Evaluate Efficacy and Safety of α-KA Tab With Low Protein Diet (LPD) in Delaying the Progress of Type 2 Diabetic Nephropathy (DN)
NCT00363987
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
2. Patients: maintenance hemodialysis patients with secondary hyperparathyroidism (SHPT).
3. Palicalcitol injection
4. Follow-up The patients are followed up for 1 year.
5. Statistical methods All statistical tests are conducted by two-sided test, and the first type of error is 0.05 (α value) to determine the statistical significance of the difference. Quantitative data includ efficacy, laboratory test indicators, such as the number of cases, mean, median, standard deviation and range description. Qualitative data includ comorbidities, described in terms of frequency, composition or percentage. Statistical test: The parameter test method is preferred. If the data distribution differs greatly from the requirements of testing the hypothesis, the non-parameter test method will be used. Patients will be divided into two groups according to circulating NGAL levels before treatment; the clinical characteristics, changes of NGAL level, the efficacy of palicalcitol (changes of iPTH) and the main adverse reactions (increased blood calcium and phosphorus, progress of vascular calcification) are compared between two groups. T test or rank sum test are used for difference test. The correlation between blood NGAL level, VC score and CKD-MBD assay indexes is analyzed by pair-wise correlation and logistic multivariate regression.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Palicalcitol
Maintenance hemodialysis patients with secondary hyperparathyroidism (SHPT) treat with palicalcitol
palicalcitol
This study does not interfere with the clinical medication of the researchers, and the usage and dosage of the drugs will be recorded according to the actual use. The recommended starting dose of palicalcitol may be based on body weight, baseline iPTH, or combined with prior medication. Dose adjustment should be determined according to pre-dialysis iPTH, Ca and P. iPTH levels should be maintained at 150-300pg/ml, while Ca and P levels should be closely monitored. If hypercalcemia occurs, the dose should be reduced or medication should be discontinued until these parameters return to normal; Subsequently, the dose of palicalcitol should be restarted at a lower dose. If PTH levels decrease as a result of treatment, the dose of medication may need to be reduced accordingly. The dose adjustment interval is 2-4 weeks, and the dose can be adjusted immediately for safety reasons.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
palicalcitol
This study does not interfere with the clinical medication of the researchers, and the usage and dosage of the drugs will be recorded according to the actual use. The recommended starting dose of palicalcitol may be based on body weight, baseline iPTH, or combined with prior medication. Dose adjustment should be determined according to pre-dialysis iPTH, Ca and P. iPTH levels should be maintained at 150-300pg/ml, while Ca and P levels should be closely monitored. If hypercalcemia occurs, the dose should be reduced or medication should be discontinued until these parameters return to normal; Subsequently, the dose of palicalcitol should be restarted at a lower dose. If PTH levels decrease as a result of treatment, the dose of medication may need to be reduced accordingly. The dose adjustment interval is 2-4 weeks, and the dose can be adjusted immediately for safety reasons.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age 18-65 years old
* Haven't used anti-PTH agents within 3 months
* Signed informed consent
Exclusion Criteria
* Vitamin D poisoning
* Expected survival is less than one year
* Acute inflammations, active liver disease, tumor, hospitalization within 3 months
* Fractures, major trauma or operations within 3 months.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Xiaoyan Jia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xiaoyan Jia
Clinical Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
YXLL-KY-2022(066)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.