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Neutrophil Gelatinase-associated Lipocalin VS Vascular Calcification in Maintenance Hemodialysis Patients

NCT05720273 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-03-08

No results posted yet for this study

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.

Conditions

  • Chronic Kidney Disease-Mineral and Bone Disorder

Interventions

DRUG

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.

Sponsors & Collaborators

  • Xiaoyan Jia

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-03-31
Completion
2025-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05720273 on ClinicalTrials.gov