Clinical trial
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
Name
YXLL-KY-2022(066)
Description
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.
Trial arms
Trial start
2023-04-01
Estimated PCD
2024-03-31
Trial end
2025-03-31
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Palicalcitol
Other names:
Calcitriol, Calcimimetics
Size
80
Primary endpoint
Change from Baseline plasma NGAL levels at 12months
12months
Eligibility criteria
Inclusion criteria:
* Chronic kidney disease (CKD) maintenance hemodialysis patients with secondary hyperparathyroidism (SHPT), iPTH\>300pg/ml
* Age 18-65 years old
* Haven't used anti-PTH agents within 3 months
* Signed informed consent
Exclusion criteria:
* Allergic to vitamin D or similar drugs
* Vitamin D poisoning
* Expected survival is less than one year
* Acute inflammations, active liver disease, tumor, hospitalization within 3 months
* Fractures, major trauma or operations within 3 months.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Maintenance hemodialysis patients with secondary hyperparathyroidism', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2024-03-08
1 organization
1 product
1 indication
Organization
Xiaoyan JiaProduct
palicalcitol