Combining Hemodialysis with Hemoperfusion for Kidney Disease Treatment

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

This study is testing if adding hemoperfusion to regular hemodialysis can improve health for people with end-stage kidney disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 410 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Changhai Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05639010 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of combining hemoperfusion with standard hemodialysis in patients with end-stage renal disease. A total of 410 maintenance hemodialysis patients will be enrolled and randomized into two groups: one receiving standard hemodialysis and the other receiving hemodialysis plus hemoperfusion. The study will assess various health markers, including blood levels of β2-microglobulin, parathyroid hormone, and C-reactive protein, over a year. Participants will undergo regular evaluations to monitor their health and treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 who have been on stable maintenance hemodialysis for at least three months.

Not a fit: Patients with known allergies to the materials used in the dialysis or perfusion apparatus, or those with severe bleeding tendencies, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve the clearance of harmful substances in patients undergoing hemodialysis, potentially enhancing their overall health and quality of life.

How similar studies have performed: While the combination of hemodialysis and hemoperfusion is a novel approach, similar studies have shown promising results in improving patient outcomes.

Eligibility criteria

Inclusion Criteria:

1. Age 18-80 years, regardless of gender
2. Stable maintenance hemodialysis for ≥ 3 months with relatively fixed dialysis pattern
3. Hemodialysis treatment 3 times per week, total treatment duration ≥ 10 hours per week, vascular access unlimited
4. 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
5. Kt/V ≥ 1.2 eight weeks prior to enrollment
6. Signed informed consent form

Exclusion Criteria:

1. Known allergic reaction, contraindication or intolerance to the material of the dialyzer or perfusion apparatus
2. 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
3. Blood flow \<200 ml/min
4. Regular hemoperfusion treatment for more than 3 months and at least once every 2 weeks
5. Active bleeding or chronic gastrointestinal bleeding, or other severe bleeding tendencies or coagulation disorders
6. History of unstable angina pectoris, myocardial infarction, severe arrhythmia, pericarditis, myocarditis, cardiac surgery or peripheral vascular surgery in the last 8 weeks
7. Cerebral hemorrhage in the last 12 weeks
8. Severe heart failure (New York Heart Association class IV)
9. Acute infection, acute or critical illnesses such as severe cardiac, pulmonary, hepatic or neurological disease and malignancy
10. Pregnancy or breastfeeding
11. Participation in a clinical trial or ongoing clinical trial within 3 months
12. Expected survival of less than 1 year
13. Not considered suitable for participation in this trial by the investigator

Where this trial is running

Shanghai, Shanghai

• Changhai Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Zhiyong Guo, professor

Conditions End Stage Renal Disease