Clinical trial NCT03227770: The Benefit of Hemodialysis Plus Hemoperfusion on Mortality
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-stage Renal Disease
Keywords: Hemoperfusion
Hemodialysis
Mortality
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: RenJi Hospital
name: Ruijin Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Shanghai 6th People's Hospital
name: Changhai Hospital
name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Shanghai University of Traditional Chinese Medicine
name: Shanghai Tongji Hospital, Tongji University School of Medicine
name: Yangpu District Central Hospital Affiliated to Tongji University
First posted: 2017-07-24
Enrollment: 1362
Sex: ALL
Minimum age (years): 18
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 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).

Eligibility criteria: Patients must meet all of the following criteria are eligible:

1. Age ≥ 18 years old
2. Regular blood purification treatment at least 3 months before enrolled in this study

3) Standard Kt/V ≥ 1.2

Subjects with one of more of the following conditions will be excluded:

1. White blood cell count \< 4×10\^9/L and / or platelet count \< 100×10\^9/L
2. Cerebral hemorrhage in the past 12 weeks
3. MACEs in the past 8 weeks
4. Severe heart failure (New York Heart Association \[NYHA\] class IV)
5. Active gastrointestinal bleeding, or coagulation dysfunction
6. Malignant tumor
7. Active infection
8. Pregnancy or lactation 9) Mental disabilities

Primary outcomes:
measure: All-cause mortality
timeFrame: From date of enrollment until the end of study, assessed up to 24 months
Secondary outcomes:
measure: Cardiovascular-related mortality and major cardiovascular events (MACEs)
timeFrame: From date of enrollment until the end of study, assessed up to 24 months
measure: Evaluation of quality of life
timeFrame: From date of enrollment until the end of study, assessed up to 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
city: Shanghai
country: China
facility: Longhua Hospital Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: RenJi Hospital
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai 6th People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tongji Hospital, Tongji University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Yangpu District Central Hospital Affiliated to Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Gengru Jiang, doctoral
role: STUDY_DIRECTOR
References:
citation: 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.