RecruitingNot ApplicableNCT05639010

Effects of Hemodialysis Plus Hemoperfusion in Maintenance Hemodialysis Patients: A Clinical Study

A Multi-center, Open-label, Randomized Trial of Hemodialysis Plus Hemoperfusion on Blood β2-microglobulin (β2-MG), Parathyroid Hormone (PTH) and C Reactive Protein (CRP) Clearance in Maintenance Hemodialysis Patients


Sponsor

Changhai Hospital

Enrollment

410 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This multi-center, open-label, randomized, parallel controlled trial aims to investigate the efficacy of hemoperfusion (HP) in combination with hemodialysis (HD) by assessing blood β2-microglobulin (β2-MG), parathyroid hormone (PTH) and C reactive protein (CRP) clearance in maintenance hemodialysis patients.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a blood-cleaning technique called hemoperfusion to regular kidney dialysis can better remove harmful waste products from the blood in people who need long-term dialysis. **You may be eligible if...** - You are between 18 and 80 years old - You have been on regular kidney dialysis (hemodialysis) for at least 3 months - You receive dialysis 3 times per week for at least 10 hours total per week - Your blood tests show elevated levels of certain waste products (beta-2 microglobulin, PTH, or CRP) - Your dialysis adequacy score (Kt/V) is at least 1.2 **You may NOT be eligible if...** - You have an allergy or intolerance to dialysis equipment materials - Your blood counts or protein levels are too low - You have had serious heart problems, brain bleeding, or major surgery in the past 2 months - You are pregnant or breastfeeding - You have a serious active infection or severe heart failure - Your expected survival is less than 1 year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEregular hemodialysis

Routine blood purification therapy (including hemodialysis, hemofiltration) 3 times a week

DEVICEhemoperfusion combined with hemodialysis

Hemoperfusion combined with hemodialysis treatment will perform once a week. The hemoperfusion apparatus will use type KHA80 hemoperfusion apparatus (Zhuhai Jafron Biomedical Co., Ltd, China)


Locations(1)

Changhai Hospital

Shanghai, Shanghai Municipality, China

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NCT05639010


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