Effect of NGAL on Vascular Calcification in Hemodialysis Patients
The Effect of Neutrophil Gelatinase-associated Lipocalin Derived From Osteoblasts and Vascular Smooth Muscle Cells on Vascular Calcification in Chronic Kidney Desease and the Intervention of Paliscalcitol - Clinical Research Section
This study is testing if a treatment using palicalcitol can help reduce vascular calcification in patients on hemodialysis with secondary hyperparathyroidism and if levels of NGAL in the blood can predict how well the treatment works.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Qianfoshan Hospital Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT05720273 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of neutrophil gelatinase-associated lipocalin (NGAL) on vascular calcification in patients undergoing maintenance hemodialysis who have secondary hyperparathyroidism (SHPT). Participants will receive palicalcitol injections and will be monitored over a one-year period to assess the efficacy of the treatment and any adverse reactions related to vascular calcification. The study aims to determine how blood levels of NGAL can predict treatment outcomes and complications. Statistical analyses will be conducted to evaluate the changes in NGAL levels and their correlation with treatment efficacy and safety.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with chronic kidney disease on maintenance hemodialysis and secondary hyperparathyroidism, specifically with iPTH levels greater than 300 pg/ml.
Not a fit: Patients with allergies to vitamin D or similar drugs, or those with acute inflammatory conditions or expected survival of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for vascular calcification in hemodialysis patients, potentially enhancing their overall health outcomes.
How similar studies have performed: While this approach is novel in the context of NGAL and vascular calcification in hemodialysis patients, similar studies have shown promising results in related areas of chronic kidney disease management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Chronic kidney disease (CKD) maintenance hemodialysis patients with secondary hyperparathyroidism (SHPT), iPTH\>300pg/ml * Age 18-65 years old * Haven't used anti-PTH agents within 3 months * Signed informed consent Exclusion criteria: * Allergic to vitamin D or similar drugs * 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.
Where this trial is running
Jinan, Shandong
- The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Xiaoyan Jia
- Email: jiaxiaoyan1982@163.com
- Phone: 0086-0531-89269002
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.