Benefits of Hemodialysis Plus Hemoperfusion: A Clinical Study

Last updated: December 8, 2024
Sponsor: Changhai Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

hemoperfusion combined with hemodialysis

regular hemodialysis

Clinical Study ID

NCT05639010
CHEC2022-207
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-80 years, regardless of gender

  2. Stable maintenance hemodialysis for ≥ 3 months with relatively fixed dialysispattern

  3. Hemodialysis treatment 3 times per week, total treatment duration ≥ 10 hours perweek, 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

Exclusion Criteria:

  1. Known allergic reaction, contraindication or intolerance to the material of thedialyzer 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 2weeks

  5. Active bleeding or chronic gastrointestinal bleeding, or other severe bleedingtendencies or coagulation disorders

  6. History of unstable angina pectoris, myocardial infarction, severe arrhythmia,pericarditis, myocarditis, cardiac surgery or peripheral vascular surgery in thelast 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

Study Design

Total Participants: 410
Treatment Group(s): 2
Primary Treatment: hemoperfusion combined with hemodialysis
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
December 31, 2025

Study Description

In this HD/HP vs HD trial, the investigators plan to enroll 410 maintenance hemodialysis patients. Twelve medical centers in the Shanghai metropolitan area have expressed interest in participating. Participants will be randomized into 2 groups after a 1-month washout period. The control group (205 patients) will be treated with hemodialysis or hemofiltration with a frequency of 3 times/week; the experimental group (205 patients) will be treated with Jafron KHA80 hemoperfusion apparatus in addition to hemodialysis or hemofiltration with a frequency of 1 time/week. Follow-up data before the last dialysis at 4, 12, 24, 36 and 52 weeks of treatment were collected from both groups, including the following: routine physical examination, laboratory tests (blood routine, blood biochemistry, β2-MG, PTH, CRP, liver/kidney function, coagulation system tests, etc.), chest X-ray, electrocardiogram and cardiac ultrasound. Dialysis adequacy as defined by standard Kt/V will be calculated. Comorbidities, combined medications and adverse events will also be captured. The primary outcomes will include change in blood β2-MG, PTH and CRP values. Secondary outcomes will include change values for serum protein-bound toxins (e.g., p-Cresol sulfate, indophenol sulphate), improvement in patient quality of life (Kidney Disease Quality of Life Short Form), sleep disturbance (Pittsburgh Sleep Quality Index) and pruritus (Duo's pruritus score).

Connect with a study center

  • Changhai Hospital

    Shanghai, Shanghai 200433
    China

    Active - Recruiting

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