Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT07111260

Efficacy of pHA130 Hemoadsorption for 4 Hours (p4H Study)

Led by Peking University People's Hospital · Updated on 2025-08-08

34

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is an open-label, randomized, crossover study to evaluate the efficacy of extending the duration of hemoadsorption (HA) combined with hemodialysis (HD) from 2 hours to 4 hours for clearing protein-bound uremic toxins, such as Indoxyl Sulfate (IS), in stable maintenance hemodialysis patients. Patients will be randomized to receive either 2-hour HA or 4-hour HA once a week for 8 weeks, then cross over to the other treatment for another 8 weeks after a 2-week washout period. The primary endpoint is the reduction rate of IS.

CONDITIONS

Official Title

Efficacy of pHA130 Hemoadsorption for 4 Hours (p4H Study)

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years, regardless of gender
  • Stable maintenance hemodialysis for at least 3 months with a fixed dialysis regimen
  • Receiving hemodialysis 3 times per week, each session lasting at least 4 hours
  • Single-pool Kt/V of 1.2 or higher within 8 weeks prior to enrollment
  • Willing and able to sign the informed consent form
Not Eligible

You will not qualify if you...

  • Life expectancy less than 1 year
  • White blood cell count less than 4 �d7 10�b9/L and/or platelet count less than 60 �d7 10�b9/L
  • Active or chronic gastrointestinal bleeding or diagnosed coagulation disorders
  • Active malignant tumor
  • Active infection
  • Pregnant or breastfeeding
  • Participation in another clinical trial within the past month or currently enrolled
  • Deemed unsuitable for the study by the investigator

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

Peking University People's Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

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Research Team

L

Liangying Gan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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