End Stage Renal DiseaseNCT05639010
Effects of Hemodialysis Plus Hemoperfusion in Maintenance Hemodialysis Patients: A Clinical Study
A study testing regular hemodialysis and hemoperfusion combined with hemodialysis in people with End Stage Renal Disease, run by Changhai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- regular hemodialysis and hemoperfusion combined with hemodialysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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).
- Conditions
- End Stage Renal Disease
- Being tested
- regular hemodialysis, hemoperfusion combined with hemodialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regular hemodialysisDevice
Routine blood purification therapy (including hemodialysis, hemofiltration) 3 times a week
hemoperfusion combined with hemodialysisDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| regular hemodialysis | Active comparator | Routine blood purification therapy (including hemodialysis, hemofiltration) 3 times a week Receives: 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 Receives: Device: regular hemodialysis; Device: hemoperfusion combined with hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment on the clearance of serum protein-bound toxin (e.g., p-Cresol sulfate, indophenol sulphate) in maintenance hemodialysis patients
Measured: From date of enrollment until the end of study, assessed up to 52 weeks
Improvement in patients' quality of life
Assessment of quality of life using the Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire
Measured: From date of enrollment until the end of study, assessed up to 52 weeks
Improvement in patients' sleep disturbance
Assessment of sleep disturbance using the Pittsburgh Sleep Quality Index (PSQI)
Measured: From date of enrollment until the end of study, assessed up to 52 weeks
Improvement in patients' pruritus
Assessment of pruritus using the Duo's pruritus score
Measured: From date of enrollment until the end of study, assessed up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start1 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhiyong Guo, professor, Study director, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639010
- Sponsor's protocol ID
- CHEC2022-207
- Status last verified
- Jun 2025
- First submitted
- 6 Nov 2022
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the publication article, after deidentification (text, tables, figures, and appendices), will be shared.
Publications
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.
PubMed 41224301
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05639010
- Acronym / sponsor ID
- CHEC2022-207
- Conditions
- End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| regular hemodialysis | Active comparator | Device: regular hemodialysisRoutine blood purification therapy (including hemodialysis, hemofiltration) 3 times a week |
| hemoperfusion combined with hemodialysis | Experimental | Device: regular hemodialysis, Device: hemoperfusion combined with hemodialysisRoutine blood purification therapy 3 times a week + Combination of hemodialysis and hemoperfusion treatment once a week |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| regular hemodialysisRoutine blood purification therapy (including hemodialysis, hemofiltration) 3 times a week | Device | hemoperfusion combined with hemodialysis, regular hemodialysis |
| hemoperfusion combined with hemodialysisHemoperfusion combined with hemodialysis treatment will perform once a week. The hemoperfusion apparatus will use type KHA80 hemoperfusion apparatus (Zhuhai Jafron Biomedical Co., Ltd, China) | Device | hemoperfusion combined with hemodialysis |
Primary outcome
Changes in blood β2-microglobulin (β2-MG) values
Time frame: From date of enrollment until the end of study, assessed up to 52 weeks
Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment on the clearance of blood β2-MG in maintenance hemodialysis patients
Changes in blood Parathyroid Hormone (PTH) values
Time frame: From date of enrollment until the end of study, assessed up to 52 weeks
Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment on the clearance of blood PTH in maintenance hemodialysis patients
Changes in blood C Reactive Protein (CRP) values
Time frame: From date of enrollment until the end of study, assessed up to 52 weeks
Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment on the clearance of blood CRP in maintenance hemodialysis patients
4 secondary outcomes
Change in serum protein-bound toxin (e.g., p-Cresol sulfate, indophenol sulphate) values
Time frame: From date of enrollment until the end of study, assessed up to 52 weeks
Improvement in patients' quality of life
Time frame: From date of enrollment until the end of study, assessed up to 52 weeks
Improvement in patients' sleep disturbance
Time frame: From date of enrollment until the end of study, assessed up to 52 weeks
Improvement in patients' pruritus
Time frame: From date of enrollment until the end of study, assessed up to 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Derived from this study: PubMed 41224301Huang 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the publication article, after deidentification (text, tables, figures, and appendices), will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhiyong Guo, professor study director
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing regular hemodialysis and hemoperfusion combined with hemodialysis in people with End Stage Renal Disease, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in blood β2-microglobulin (β2-MG) values (time frame: From date of enrollment until the end of study, assessed up to 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05639010, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.