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NCT05639010Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 23 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
410 (estimated)
First submitted
6 Nov 2022
Start date
1 Jan 2023
Primary completion date
31 Dec 2026
Lead sponsor
Changhai Hospital
NCT number
NCT05639010

What you commit to

  • Study type: Interventional
  • Planned participants: 410
  • From 1 Jan 2023 to the primary completion date, 31 Dec 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

  • Known allergic reaction, contraindication or intolerance to the material of the dialyzer or perfusion apparatus
  • Active bleeding or chronic gastrointestinal bleeding, or other severe bleeding tendencies or coagulation disorders
  • History of unstable angina pectoris, myocardial infarction, severe arrhythmia, pericarditis, myocarditis, cardiac surgery or peripheral vascular surgery in the last 8 weeks
  • Cerebral hemorrhage in the last 12 weeks
  • Severe heart failure (New York Heart Association class IV)
  • Acute infection, acute or critical illnesses such as severe cardiac, pulmonary, hepatic or neurological disease and malignancy

Lab values

  • Test indicators meeting one or more of the following: white blood cell \<4 x 10\^9/L, platelet count \<60 x 10\^9/L, serum albumin \<30 g/L

Other

  • Blood flow \<200 ml/min
  • Regular hemoperfusion treatment for more than 3 months and at least once every 2 weeks
  • Pregnancy or breastfeeding
  • Participation in a clinical trial or ongoing clinical trial within 3 months
  • Expected survival of less than 1 year
  • Not considered suitable for participation in this trial by the investigator

Who the study is looking for

  • Age 18-80 years, regardless of gender
  • Stable maintenance hemodialysis for ≥ 3 months with relatively fixed dialysis pattern
  • Hemodialysis treatment 3 times per week, total treatment duration ≥ 10 hours per week, vascular access unlimited
  • Blood β2-MG \> 30 mg/L and/or 300 pg/ml \< immunoreactive parathyroid hormone (iPTH) \< 800 pg/ml and/or CRP ≥ 16.2 pg/ml
  • Kt/V ≥ 1.2 eight weeks prior to enrollment
  • Signed informed consent form

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Changhai Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

Related publications

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