A Phase 4 interventional study of palicalcitol in Chronic Kidney Disease-Mineral and Bone Disorder, sponsored by Xiaoyan Jia. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-08.
Sponsored by Xiaoyan Jia · Phase 4, Interventional, and Other
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.
73 studies on the registry are indexed under Chronic Kidney Disease-Mineral and Bone Disorder; 20 are open to participants now.
This study's planned enrollment of 80 is above the median of 54 across 34 interventional studies indexed under Chronic Kidney Disease-Mineral and Bone Disorder.
Browse Chronic Kidney Disease-Mineral and Bone Disorder studies →This is the only study on the registry with Xiaoyan Jia as lead sponsor.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Maintenance hemodialysis patients with secondary hyperparathyroidism (SHPT) treat with palicalcitol
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.
Also known as: Calcitriol, Calcimimetics
Change from Baseline plasma NGAL levels at 12months
Elisa
Time frame: 12months
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.
Time frame: 12months
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.
Time frame: 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.
Time frame: 12months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Apr 2023 (actual). Primary completion is estimated for Mar 2024, 11 months after the start.
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Studies of the drug tested here: Calcitriol
Chronic Kidney Disease-Mineral and Bone Disorder →