Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06233838

Multi-center Clinical Study on Hemoperfusion of KHA80

Led by First Affiliated Hospital of Fujian Medical University · Updated on 2025-01-14

394

Participants Needed

1

Research Sites

124 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To evaluate the decreasing rate of blood IL-6, β2-MG and PTH in maintenance hemodialysis patients in the 52nd week compared with routine hemodialysis.

CONDITIONS

Official Title

Multi-center Clinical Study on Hemoperfusion of KHA80

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, any sex
  • Diagnosed with stage 5 chronic kidney disease (CKD5) with eGFR ≤ 15 ml/min/1.73m2 according to 2012 KDIGO guidelines
  • Receiving regular hemodialysis or hemodialysis filtration for 4 hours, at least twice a week, for 3 months or more
  • Blood beta-2 microglobulin ≥ 30 mg/L and/or parathyroid hormone ≥ 600 pg/mL and/or interleukin-6 ≥ 16.2 pg/mL
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Known allergy, intolerance, or contraindication to dialyzer or hemoperfusion materials
  • Severe bleeding tendency, active bleeding, or definite coagulation dysfunction with platelet count < 60×10⁹/L
  • Hemodialysis blood flow less than 200 ml/min
  • Kt/V less than 1.2
  • Serum albumin less than 30 g/L
  • Parathyroid gland removal surgery within one year
  • Low blood pressure and severe heart or lung failure
  • Pregnant or breastfeeding women, or planning pregnancy within one year
  • Infection, history of cancer, or active rheumatic immune disease
  • Life expectancy less than one year
  • Participation in other clinical research currently or within 30 days
  • Other conditions judged unsuitable by the researcher

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China, 350000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Multi-center Clinical Study on Hemoperfusion of KHA80 | DecenTrialz