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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
| RenJi Hospital | OTHER |
| Ruijin Hospital | OTHER |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| regular hemodialysis | Active Comparator | Blood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment ≥10 hours per week |
|
| hemoperfusion combined with hemodialysis | Experimental | Combination of hemodialysis and hemoperfusion treatment at least once every two week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hemoperfusion combined with hemodialysis | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment | From date of enrollment until the end of study, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From date of enrollment until the end of study, assessed up to 24 months |
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Patients must meet all of the following criteria are eligible:
3) Standard Kt/V ≥ 1.2
Subjects with one of more of the following conditions will be excluded:
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| Name | Affiliation | Role |
|---|---|---|
| Gengru Jiang, doctoral | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Shanghai | Shanghai Municipality | 200000 | China | ||
| Longhua Hospital Shanghai University of Traditional Chinese Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41904134 | Derived | 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. | |
| 30056391 |
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The mortality data will be shared
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 14, 2018 | Apr 15, 2018 | Prot_002.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D006435 | Renal Dialysis |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
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| OTHER |
| Shanghai 6th People's Hospital | OTHER |
| Changhai Hospital | OTHER |
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | OTHER |
| Shanghai University of Traditional Chinese Medicine | OTHER |
| Shanghai Tongji Hospital, Tongji University School of Medicine | OTHER |
| Yangpu District Central Hospital Affiliated to Tongji University | OTHER |
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| hemodialysis | Device | Blood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment ≥10 hours per week |
|
| Evaluation of quality of life | Assessment of quality of life using the KDQOL-SF (Kidney Disease Quality of Life Short Form) questionnaire | From date of enrollment until the end of study, assessed up to 24 months |
| Shanghai |
| Shanghai Municipality |
| 200000 |
| China |
| RenJi Hospital | Shanghai | Shanghai Municipality | 200000 | China |
| Ruijin Hospital | Shanghai | Shanghai Municipality | 200000 | China |
| Shanghai 6th People's Hospital | Shanghai | Shanghai Municipality | 200000 | China |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200000 | China |
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | 200000 | China |
| Shanghai Tongji Hospital, Tongji University School of Medicine | Shanghai | Shanghai Municipality | 200000 | China |
| Shanghai Zhongshan Hospital | Shanghai | Shanghai Municipality | 200000 | China |
| Yangpu District Central Hospital Affiliated to Tongji University | Shanghai | Shanghai Municipality | 200000 | China |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200092 | China |
| Lu 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |