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Clinical Trial Details

Trial ID: L1058
Source ID: NCT05720273
Associated Drug: Palicalcitol
Title: Neutrophil Gelatinase-associated Lipocalin VS Vascular Calcification in Maintenance Hemodialysis Patients
Acronym: NGAL
Status: RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Disease-Mineral and Bone Disorder
Interventions: DRUG: palicalcitol
Outcome Measures: Primary: Change from Baseline plasma NGAL levels at 12months, Elisa, 12months | Secondary: Change from baseline vascular calcification at 12months, Coronary calcification scores (CACS) from serial computed tomographic images with the Agatston method is used to evaluate cardio-vascular calcification, 1 point=130\~199HU;2 points=200\~299HU;3 points =300\~399HU;4 points≥400HU. Abdominal aortic calcification score (AACS) is measured by Kauppila method from lateral dual-energy X-ray absorptiometry spine, 0-3 points. Anterior chest radiographs is used to perform simple calcification scores for aortic arch knob, 0-100%. Higher scores mean a worse outcome., 12months | Other: Change from baseline Chronic Kidney Disease-Mineral and Bone Disorder associated laboratory tests at 12months, Serum calcium and phosphorus are analyzed by Beckman automatic biochemical analyzer in our laboratory center. Blood iPTH measured by ELISA., 12months|Change from baseline bone density tests at 12months, Quantitative computed tomography (QCT) measurements are performed at the lumbar spine (mean of L 1 and L 2 entire vertebral bodies, excluding posterior processes) and hip., 12months
Sponsor/Collaborators: Sponsor: Xiaoyan Jia
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 80
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-04-01
Completion Date: 2025-03-31
Results First Posted:
Last Update Posted: 2024-03-08
Locations: The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Jinan, Shandong, China
URL: https://clinicaltrials.gov/show/NCT05720273