End-stage Renal DiseaseNCT03227770
The Benefit of Hemodialysis Plus Hemoperfusion on Mortality
A study testing hemoperfusion combined with hemodialysis and hemodialysis in people with End-stage Renal Disease, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 11 sites in China.
Trial summary
This multi-center, open-label, randomized controlled trial aims to investigate the efficacy of hemoperfusion (HP) combined with hemodialysis (HD) by evaluating all-cause mortality and cardiovascular mortality in maintenance hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- hemoperfusion combined with hemodialysis and hemodialysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,362 participants
- Where
- 11 sitesChina
- Study dates
- 1 Dec 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Patients must meet all of the following criteria are eligible:
- Age ≥ 18 years old
- Regular blood purification treatment at least 3 months before enrolled in this study
- Standard Kt/V ≥ 1.2
Subjects with one of more of the following conditions will be excluded:
- White blood cell count < 4×10^9/L and / or platelet count < 100×10^9/L
- Cerebral hemorrhage in the past 12 weeks
- MACEs in the past 8 weeks
- Severe heart failure (New York Heart Association [NYHA] class IV)
- Active gastrointestinal bleeding, or coagulation dysfunction
- Malignant tumor
- Active infection
- Pregnancy or lactation 9) Mental disabilities
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Changhai Hospital
Shanghai, Shanghai Municipality, 200000
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200000
RenJi Hospital
Shanghai, Shanghai Municipality, 200000
Ruijin Hospital
Shanghai, Shanghai Municipality, 200000
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, 200000
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200000
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, 200000
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200000
Yangpu District Central Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, 200000
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
About this study
Official title: A Randomized, Open-label, Multi-centre Trial Comparing Hemodialysis Plus Hemoperfusion Versus Hemodialysis Alone in Adult Patients With End-stage Renal Disease (HD/HPvsHD)
This multi-center, open-label, randomized controlled trial aims to investigate the efficacy of hemoperfusion (HP) combined with hemodialysis (HD) by evaluating all-cause mortality and cardiovascular mortality in maintenance hemodialysis patients.
Read the detailed description
In this HD/HPvsHD trial, we plan to enroll 1364 maintenance hemodialysis patients. Eleven medical centers in Shanghai Metropolitan area have explicitly expressed interest to participate. Participants will be randomized to receive hemodialysis plus hemoperfusion or hemodialysis alone at a 1:1 ratio after 1-month run-in period. In both arms, patients will receive lBlood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment at least 10 hours per week. In the experiment group, in addition to the treatments in the control arm, hemoperfusion will be conducted at least once every two weeks using a HA130 resin hemoperfusion apparatus containing 130ml resin. Follow-up is scheduled at 3, 6, 12, 18, 24 and up to 48 months after randomization, and will consist the following: routine physical examinations, standard lab panels (blood routine, liver/kidney functions, tests of the coagulation system, etc.), chest X-ray, electrocardiogram, echocardiography, heart function rating (based on New York Heart Association grading). Dialysis adequacy defined by standard Kt/V will be calculated. Adverse events will be assessed according to the international conference on harmonization guidelines. The primary outcomes will include 24-month all-cause mortality. Secondary outcomes will include cardiovascular-related mortality, the occurrence of major cardiovascular events and the quality of life (Kidney Disease Quality of Life Short Form).
- Conditions
- End-stage Renal Disease
- Being tested
- hemoperfusion combined with hemodialysis, hemodialysis
- Keywords
- Hemoperfusion, Hemodialysis, Mortality
- 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.
hemoperfusion combined with hemodialysisDevice
Hemoperfusion combined with hemodialysis treatment will perform at least once every two week. The hemoperfusion apparatus will use type HA130 resin hemoperfusion apparatus (Zhuhai Jafron Biomedical Co., Ltd, China)
hemodialysisDevice
Blood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment ≥10 hours per week
| Study group | Role | What they receive |
|---|---|---|
| regular hemodialysis | Active comparator | Blood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment ≥10 hours per week Receives: Device: hemodialysis |
| hemoperfusion combined with hemodialysis | Experimental | Combination of hemodialysis and hemoperfusion treatment at least once every two week Receives: Device: hemoperfusion combined with hemodialysis; Device: hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment
Measured: From date of enrollment until the end of study, assessed up to 24 months
Secondary outcomes (2)
Cardiovascular-related mortality and major cardiovascular events (MACEs)
Major cardiovascular events events including angina pectoris, acute myocardial infarction, severe arrhythmia, congestive heart failure, myocarditis, pericarditis, cardiac surgery or peripheral vascular surgery, stroke and peripheral vascular disease
Measured: From date of enrollment until the end of study, assessed up to 24 months
Evaluation of quality of life
Assessment of quality of life using the KDQOL-SF (Kidney Disease Quality of Life Short Form) questionnaire
Measured: From date of enrollment until the end of study, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Dec 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- 1,362 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, RenJi Hospital, Ruijin Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 6th People's Hospital, Changhai Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai University of Traditional Chinese Medicine, Shanghai Tongji Hospital, Tongji University School of Medicine, Yangpu District Central Hospital Affiliated to Tongji University
- Responsible party
- Principal investigator, Gengru Jiang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Gengru Jiang, doctoral, Study director, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227770
- Sponsor's protocol ID
- XH-16-017
- Status last verified
- Aug 2022
- First submitted
- 20 Jul 2017
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The mortality data will be shared
Publications
Lu W, Zhang X, Guo Z, Deng Y, Ni Z, Zhou R, Wang N, Yu C, Ding X, Yu Q, Wang Y, Chen X, Huang H, Ji G, Jiang G. Hemoadsorption combined with hemodialysis versus hemodialysis alone on mortality in end-stage kidney disease: a randomized, open-label, multicenter trial. Nat Commun. 2026 Mar 28;17(1):4537. doi: 10.1038/s41467-026-71079-7.
PubMed 41904134Lu W, Jiang GR; HD/HP versus HD trial Group. Randomised, open-label, multicentre trial comparing haemodialysis plus haemoperfusion versus haemodialysis alone in adult patients with end-stage renal disease (HD/HP vs HD): study protocol. BMJ Open. 2018 Jul 28;8(7):e022169. doi: 10.1136/bmjopen-2018-022169.
PubMed 30056391
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multi-centre Trial Comparing Hemodialysis Plus Hemoperfusion Versus Hemodialysis Alone in Adult Patients With End-stage Renal Disease (HD/HPvsHD)
- ClinicalTrials.gov ID
- NCT03227770
- Acronym / sponsor ID
- XH-16-017
- Conditions
- End-stage Renal Disease
- Keywords
- Hemoperfusion, Hemodialysis, Mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,362 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, RenJi Hospital, Ruijin Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 6th People's Hospital, Changhai Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai University of Traditional Chinese Medicine, Shanghai Tongji Hospital, Tongji University School of Medicine, Yangpu District Central Hospital Affiliated to Tongji University
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 24 Jul 2017 (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 controlled trial aims to investigate the efficacy of hemoperfusion (HP) combined with hemodialysis (HD) by evaluating all-cause mortality and cardiovascular mortality in maintenance hemodialysis patients.
Detailed description
In this HD/HPvsHD trial, we plan to enroll 1364 maintenance hemodialysis patients. Eleven medical centers in Shanghai Metropolitan area have explicitly expressed interest to participate. Participants will be randomized to receive hemodialysis plus hemoperfusion or hemodialysis alone at a 1:1 ratio after 1-month run-in period. In both arms, patients will receive lBlood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment at least 10 hours per week. In the experiment group, in addition to the treatments in the control arm, hemoperfusion will be conducted at least once every two weeks using a HA130 resin hemoperfusion apparatus containing 130ml resin. Follow-up is scheduled at 3, 6, 12, 18, 24 and up to 48 months after randomization, and will consist the following: routine physical examinations, standard lab panels (blood routine, liver/kidney functions, tests of the coagulation system, etc.), chest X-ray, electrocardiogram, echocardiography, heart function rating (based on New York Heart Association grading). Dialysis adequacy defined by standard Kt/V will be calculated. Adverse events will be assessed according to the international conference on harmonization guidelines. The primary outcomes will include 24-month all-cause mortality. Secondary outcomes will include cardiovascular-related mortality, the occurrence of major cardiovascular events and the quality of life (Kidney Disease Quality of Life Short Form).
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: hemodialysisBlood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment ≥10 hours per week |
| hemoperfusion combined with hemodialysis | Experimental | Device: hemoperfusion combined with hemodialysis, Device: hemodialysisCombination of hemodialysis and hemoperfusion treatment at least once every two week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| hemoperfusion combined with hemodialysisHemoperfusion combined with hemodialysis treatment will perform at least once every two week. The hemoperfusion apparatus will use type HA130 resin hemoperfusion apparatus (Zhuhai Jafron Biomedical Co., Ltd, China) | Device | hemoperfusion combined with hemodialysis |
| hemodialysisBlood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment ≥10 hours per week | Device | hemoperfusion combined with hemodialysis, regular hemodialysis |
Primary outcome
All-cause mortality
Time frame: From date of enrollment until the end of study, assessed up to 24 months
Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment
2 secondary outcomes
Cardiovascular-related mortality and major cardiovascular events (MACEs)
Time frame: From date of enrollment until the end of study, assessed up to 24 months
Evaluation of quality of life
Time frame: From date of enrollment until the end of study, assessed up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Derived from this study: PubMed 41904134Lu W, Zhang X, Guo Z, Deng Y, Ni Z, Zhou R, Wang N, Yu C, Ding X, Yu Q, Wang Y, Chen X, Huang H, Ji G, Jiang G. Hemoadsorption combined with hemodialysis versus hemodialysis alone on mortality in end-stage kidney disease: a randomized, open-label, multicenter trial. Nat Commun. 2026 Mar 28;17(1):4537. doi: 10.1038/s41467-026-71079-7.
- Derived from this study: PubMed 30056391Lu W, Jiang GR; HD/HP versus HD trial Group. Randomised, open-label, multicentre trial comparing haemodialysis plus haemoperfusion versus haemodialysis alone in adult patients with end-stage renal disease (HD/HP vs HD): study protocol. BMJ Open. 2018 Jul 28;8(7):e022169. doi: 10.1136/bmjopen-2018-022169.
- Individual participant dataSharing planned: Undecided. The mortality data 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.
Gengru Jiang, doctoral study director
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hemoperfusion combined with hemodialysis and hemodialysis in people with End-stage Renal Disease, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 11 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
All-cause mortality (time frame: From date of enrollment until the end of study, assessed up to 24 months). 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 NCT03227770, which also lists 2 linked publications.
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 29 Aug 2022.