The Benefit of Hemodialysis Plus Hemoperfusion on Mortality

End-stage Renal Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03227770
• Other study ID #: XH-16-017
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2022
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1362
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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)
• hemodialysis
Blood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment =10 hours per week

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai
China	Longhua Hospital Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai
China	RenJi Hospital	Shanghai	Shanghai
China	Ruijin Hospital	Shanghai	Shanghai
China	Shanghai 6th People's Hospital	Shanghai	Shanghai
China	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University	Shanghai	Shanghai
China	Shanghai Tongji Hospital, Tongji University School of Medicine	Shanghai	Shanghai
China	Shanghai Zhongshan Hospital	Shanghai	Shanghai
China	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Yangpu District Central Hospital Affiliated to Tongji University	Shanghai	Shanghai

Sponsors (11)

Lead Sponsor

Collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Changhai Hospital, RenJi Hospital, Ruijin Hospital, Shanghai 6th People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai Zhongshan Hospital, Yangpu District Central Hospital Affiliated to Tongji University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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