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

NCT05639010 | Active Not Recruiting

• 1 other identifier: CHEC2022-207
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (3)

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

  Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment on the clearance of blood β2-MG in maintenance hemodialysis patients

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

• Changes in blood Parathyroid Hormone (PTH) values

  Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment on the clearance of blood PTH in maintenance hemodialysis patients

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

• Changes in blood C Reactive Protein (CRP) values

  Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment on the clearance of blood CRP in maintenance hemodialysis patients

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

Secondary Outcomes (4)

• Change in serum protein-bound toxin (e.g., p-Cresol sulfate, indophenol sulphate) values

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

• Improvement in patients' quality of life

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

• Improvement in patients' sleep disturbance

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

• Improvement in patients' pruritus

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

Study Arms (2)

regular hemodialysis

ACTIVE COMPARATOR

Routine blood purification therapy (including hemodialysis, hemofiltration) 3 times a week

Device: regular hemodialysis

hemoperfusion combined with hemodialysis

EXPERIMENTAL

Routine blood purification therapy 3 times a week + Combination of hemodialysis and hemoperfusion treatment once a week

Device: regular hemodialysis; Device: hemoperfusion combined with hemodialysis

Interventions

regular hemodialysis DEVICE

Routine blood purification therapy (including hemodialysis, hemofiltration) 3 times a week

hemoperfusion combined with hemodialysis; regular hemodialysis

hemoperfusion combined with hemodialysis DEVICE

Hemoperfusion combined with hemodialysis treatment will perform once a week. The hemoperfusion apparatus will use type KHA80 hemoperfusion apparatus (Zhuhai Jafron Biomedical Co., Ltd, China)

hemoperfusion combined with hemodialysis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (1)

• Huang W, Zhang L, Wu H, Chen W, Guo Z. Effects of combined haemodialysis-haemoadsorption therapy in maintenance haemodialysis patients: study protocol for a multicentre, open-label, randomised, parallel controlled trial. BMJ Open. 2025 Nov 12;15(11):e107017. doi: 10.1136/bmjopen-2025-107017.

  PMID: 41224301 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Study Officials

• Zhiyong Guo, professor

  Changhai Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2022
• First Posted: December 6, 2022
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 23, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The available data period begins 3 months and ends 5 years following the article's publication.
• Access Criteria: Investigators who provide a methodologically sound proposal for scientific research with non-commercial purposes will be able to access the IPD and supporting information. Deidentified participant data that underlie the results reported in the publication article will be shared, which can be available from Professor Zhiyong Guo (contacting email: drguozhiyong@163.com, ORCID: Shenneike66). Proposals should be directed to drguozhiyong@163.com. To gain access, data requestors will need to sign a data access agreement.

Locations

CN (1)