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NCT07111260Recruiting

Efficacy of pHA130 Hemoadsorption for 4 Hours (p4H Study)

Comparison of the Efficacy of Hemoadsorption Combined With Hemodialysis of Different Treatment Durations in Clearing Protein-Bound Uremic Toxins: A Randomized Crossover Controlled Trial

Source: ClinicalTrials.gov · Last updated 8 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
34 (estimated)
First submitted
28 Jul 2025
Start date
1 Jul 2025
Primary completion date
Mar 2026
Lead sponsor
Peking University People's Hospital
NCT number
NCT07111260

What you commit to

  • Study type: Interventional
  • Planned participants: 34
  • From 1 Jul 2025 to the primary completion date, Mar 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Active or chronic gastrointestinal bleeding, or diagnosed coagulation disorders
  • Active malignant tumor
  • Active infection

Lab values

  • White blood cell count \< 4 × 10⁹/L and/or platelet count \< 60 × 10⁹/L

Other

  • Life expectancy less than 1 year
  • Pregnant or breastfeeding
  • Participation in another clinical trial within the past month or currently enrolled in one
  • Deemed unsuitable for the study by the investigator

Who the study is looking for

  • Age between 18 and 75 years, regardless of gender
  • Stable maintenance hemodialysis for ≥3 months, with a relatively fixed dialysis regimen
  • Receiving hemodialysis 3 times per week, each session lasting ≥4 hours
  • Single-pool Kt/V (spKt/V) ≥1.2 within 8 weeks prior to enrollment
  • Willing and able to sign the informed consent form

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking University People's Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.