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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,362

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach

1 country

11 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.1 years study duration

First Submitted

Initial submission to the registry

July 20, 2017

Completed

4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed

4 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed

4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed

Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

4.1 years

First QC Date

July 20, 2017

Last Update Submit

August 24, 2022

Conditions

End-stage Renal Disease

Keywords

HemoperfusionHemodialysisMortality

Outcome Measures

Primary Outcomes (1)

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 Outcomes (2)

Cardiovascular-related mortality and major cardiovascular events (MACEs)
From date of enrollment until the end of study, assessed up to 24 months
Evaluation of quality of life
From date of enrollment until the end of study, assessed up to 24 months

Study Arms (2)

regular hemodialysis

ACTIVE COMPARATOR

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

Device: hemodialysis

hemoperfusion combined with hemodialysis

EXPERIMENTAL

Combination of hemodialysis and hemoperfusion treatment at least once every two week

Device: hemoperfusion combined with hemodialysisDevice: hemodialysis

Interventions

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)

hemoperfusion combined with hemodialysis

hemodialysisDEVICE

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

hemoperfusion combined with hemodialysisregular hemodialysis

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.