Clinical trial NCT05639010: Benefits of Hemodialysis Plus Hemoperfusion: A Clinical Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End Stage Renal Disease
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

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

Primary outcomes:
measure: Changes in blood β2-microglobulin (β2-MG) values
timeFrame: From date of enrollment until the end of study, assessed up to 52 weeks
measure: Changes in blood Parathyroid Hormone (PTH) values
timeFrame: From date of enrollment until the end of study, assessed up to 52 weeks
measure: Changes in blood C Reactive Protein (CRP) values
timeFrame: From date of enrollment until the end of study, assessed up to 52 weeks
Secondary outcomes:
measure: Change in serum protein-bound toxin (e.g., p-Cresol sulfate, indophenol sulphate) values
timeFrame: From date of enrollment until the end of study, assessed up to 52 weeks
measure: Improvement in patients' quality of life
timeFrame: From date of enrollment until the end of study, assessed up to 52 weeks
measure: Improvement in patients' sleep disturbance
timeFrame: From date of enrollment until the end of study, assessed up to 52 weeks
measure: Improvement in patients' pruritus
timeFrame: From date of enrollment until the end of study, assessed up to 52 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Zhiyong Guo, professor
role: STUDY_DIRECTOR
References: