Active — Not RecruitingNot Applicable

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

China410 participantsStarted 2023-01-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. Known allergic reaction, contraindication or intolerance to the material of the dialyzer or perfusion apparatus
✕. 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
✕. Blood flow \<200 ml/min
✕. Regular hemoperfusion treatment for more than 3 months and at least once every 2 weeks
✕. 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

What they're measuring

Changes in blood β2-microglobulin (β2-MG) values

Timeframe: From date of enrollment until the end of study, assessed up to 52 weeks

Changes in blood Parathyroid Hormone (PTH) values

Timeframe: From date of enrollment until the end of study, assessed up to 52 weeks

Changes in blood C Reactive Protein (CRP) values

Timeframe: From date of enrollment until the end of study, assessed up to 52 weeks

Trial details

NCT IDNCT05639010

SponsorChanghai Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More End Stage Renal Disease trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. Known allergic reaction, contraindication or intolerance to the material of the dialyzer or perfusion apparatus
✕. 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
✕. Blood flow \<200 ml/min
✕. Regular hemoperfusion treatment for more than 3 months and at least once every 2 weeks
✕. 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

What they're measuring

Changes in blood β2-microglobulin (β2-MG) values

Timeframe: From date of enrollment until the end of study, assessed up to 52 weeks

Changes in blood Parathyroid Hormone (PTH) values

Timeframe: From date of enrollment until the end of study, assessed up to 52 weeks

Changes in blood C Reactive Protein (CRP) values

Timeframe: From date of enrollment until the end of study, assessed up to 52 weeks