NCT03227770

The Benefit of Hemodialysis Plus Hemoperfusion on Mortality

A Randomized, Open-label, Multi-centre Trial Comparing Hemodialysis Plus Hemoperfusion Versus Hemodialysis Alone in Adult Patients With End-stage Renal Disease (HD/HPvsHD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,362 (actual)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• End-stage Renal Disease

Interventions

Type	Name	Description
DEVICE	hemoperfusion combined with hemodialysis	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)
DEVICE	hemodialysis	Blood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment ≥10 hours per week

Timeline

• Start date: 2017-12-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2017-07-24
• Last updated: 2022-08-29

Locations

11 sites across 1 country: China