RecruitingPhase 4NCT05720273

Neutrophil Gelatinase-associated Lipocalin VS Vascular Calcification in Maintenance 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

Sponsor

Xiaoyan Jia

Enrollment

80 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Disease-Mineral and Bone Disorder

Summary

The goal of this observational study or clinical trial is to learn about the effect of neutrophil gelatinase-associated lipocalin (NGAL) on vascular calcification in maintenance hemodialysis patients with secondary hyperparathyroidism (SHPT). The main question it aims to answer is: the predictive effects of blood NGAL level on the efficacy of palicalcitol in the treatment of SHPT and the adverse reactions of vascular calcification progression. Participants will be treated with palicalcitol, followed up and undergo routine series of Chronic Kidney Disease-Mineral and Bone Disorder associated tests before and after treatment.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is examining a blood protein called NGAL (neutrophil gelatinase-associated lipocalin) as a potential indicator of calcium build-up in blood vessels (vascular calcification) in patients on long-term hemodialysis who also have overactive parathyroid glands (secondary hyperparathyroidism), a common complication of kidney failure. **You may be eligible if...** - You are between 18 and 65 years old on maintenance hemodialysis - You have secondary hyperparathyroidism with elevated parathyroid hormone (iPTH above 300 pg/mL) - You have not used parathyroid-lowering medications in the past 3 months **You may NOT be eligible if...** - You are allergic to vitamin D or similar compounds - You have a life expectancy of less than one year - You have had acute inflammation, active liver disease, active cancer, or been hospitalized in the past 3 months - You have had a fracture, major trauma, or surgery in the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGpalicalcitol

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.

Locations(1)

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, China

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NCT05720273

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