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

NCT05720273 | Recruiting Phase 4

• 1 other identifier: YXLL-KY-2022(066)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic Kidney Disease-Mineral and Bone Disorder; Calcitriol Receptor; Lipocalin-2; Vascular Calcification

Outcome Measures

Primary Outcomes (1)

• Change from Baseline plasma NGAL levels at 12months

  Elisa

  12months

Secondary Outcomes (1)

• Change from baseline vascular calcification at 12months

  12months

Other Outcomes (2)

• Change from baseline Chronic Kidney Disease-Mineral and Bone Disorder associated laboratory tests at 12months

  12months

• Change from baseline bone density tests at 12months

  12months

Study Arms (1)

Palicalcitol

EXPERIMENTAL

Maintenance hemodialysis patients with secondary hyperparathyroidism (SHPT) treat with palicalcitol

Drug: palicalcitol

Interventions

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.

Also known as: Calcitriol, Calcimimetics

Palicalcitol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiaoyan Jia: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Chronic Kidney Disease-Mineral and Bone Disorder; Vascular Calcification

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Calcinosis

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

Xiaoyan Jia

CONTACT

0086-0531-89269002; jiaxiaoyan1982@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Maintenance hemodialysis patients with secondary hyperparathyroidism

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: February 9, 2023
• Study Start: April 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2025
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)