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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palicalcitol | Experimental | Maintenance hemodialysis patients with secondary hyperparathyroidism (SHPT) treat with palicalcitol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| palicalcitol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline plasma NGAL levels at 12months | Elisa | 12months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoyan Jia | Contact | 0086-0531-89269002 | jiaxiaoyan1982@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital | Recruiting | Jinan | Shandong | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 10, 2022 | Jan 16, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012080 | Chronic Kidney Disease-Mineral and Bone Disorder |
| D061205 | Vascular Calcification |
| ID | Term |
|---|---|
| D012279 | Rickets |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D002117 | Calcitriol |
| ID | Term |
|---|---|
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
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Maintenance hemodialysis patients with secondary hyperparathyroidism
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|
|
| 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 |
| D007674 |
| Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D006962 | Hyperparathyroidism, Secondary |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002114 | Calcinosis |
| D002776 |
| Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |