What is the clinical evidence from this study?

Study design: RCT. Population: End-stage kidney disease (n=1362). Intervention: Hemoadsorption combined with hemodialysis (HAHD) vs. Hemodialysis alone (mainly low-flux HD plus intermittent HDF). Primary outcome: All-cause mortality (HR 0.778, 95% CI 0.609-0.994, p=0.045).

What does this research mean for the field?

Hemoadsorption combined with hemodialysis significantly reduces all-cause mortality, cardiovascular mortality, and major cardiovascular events compared to hemodialysis alone in patients with end-stage kidney disease. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

To evaluate the impact of hemoadsorption combined with hemodialysis on mortality in patients with end-stage kidney disease.

March 30, 2026Open Access

Hemoadsorption combined with hemodialysis versus hemodialysis alone on mortality in end-stage kidney disease: a randomized, open-label, multicenter trial

Key Result

Hemoadsorption combined with hemodialysis significantly reduced all-cause mortality (HR 0.778) compared to hemodialysis alone in patients with end-stage kidney disease.

Key Points

To evaluate the impact of hemoadsorption combined with hemodialysis on mortality in patients with end-stage kidney disease.
Conducted as a randomized, open-label trial across 11 centers in Shanghai, China.
Involved 1362 patients randomly assigned to receive either hemoadsorption combined with hemodialysis or hemodialysis alone.
Primary outcome was all-cause mortality; secondary outcomes included cardiovascular mortality and major cardiovascular events.
All-cause mortality was 17.1% in the hemoadsorption group compared to 21.2% in the hemodialysis group (HR: 0.778).
Cardiovascular mortality was significantly lower in the hemoadsorption group (HR: 0.659).
Major cardiovascular events were reduced with hemoadsorption (HR: 0.772).

Study Design

Type

RCT (n=1,362)

Blinding

Open-label

Randomization

1:1

Multicenter

Yes

Structured PICO

Does hemoadsorption combined with hemodialysis reduce all-cause mortality in patients with end-stage kidney disease?

Population

End-stage kidney disease patients on maintenance hemodialysis for ≥ 3 months with Kt/V ≥ 1.2, median age 64 years, 62.2% males

Intervention

Hemoadsorption combined with hemodialysis (HAHD) using an HA130 cartridge at least once every two weeks

Comparator

Hemodialysis (HD) alone (mainly low-flux HD plus intermittent HDF)

Outcome

All-cause mortalityhard clinical

Adding hemoadsorption to conventional hemodialysis significantly reduces all-cause mortality, cardiovascular mortality, and major cardiovascular events in patients with end-stage kidney disease.

Main Result

Effect estimate: HR 0.778 (95% CI 0.609-0.994)

Absolute Event Rate: 17.1% vs 21.2%

p-value: p=0.045

Limitations

HDF regimens used in the conventional HD group reflect common clinical practice in China, which may involve lower frequency and intensity than standard in Western countries
Lower than expected all-cause mortality risk in the cohort, potentially due to selection bias
Residual renal function and certain clinical symptoms were not systematically monitored
No data collected on hemoadsorption use prior to enrollment
Hemoadsorption duration was limited to two hours per session
Open-label design without an independent adjudication committee for event verification
Significant baseline imbalance in sex distribution
COVID-19 pandemic severely disrupted the collection of Quality of Life (QoL) data

Abstract

The objective of this completed, randomized, open-label trial across 11 hemodialysis centers in Shanghai, China, was to evaluate whether hemoadsorption combined with hemodialysis (HAHD) reduces mortality compared to hemodialysis (HD) alone in end-stage kidney disease patients (maintenance HD ≥ 3 months, Kt/V ≥ 1.2). We randomized 1362 patients 1:1 to receive HAHD (n = 683) or HD alone (n = 679; mainly low-flux HD plus intermittent HDF). All 1362 randomized patients were analyzed. The primary outcome was all-cause mortality, while secondary outcomes included cardiovascular mortality and major cardiovascular events. Over a median follow-up of 39.5 months, all-cause mortality occurred in 117 (17.1%) of HAHD patients compared to 144 (21.2%) of HD patients (hazard ratio HR: 0.778, 95% confidence interval CI: 0.609–0.994; P = 0.045). HAHD also significantly reduced cardiovascular mortality (HR: 0.659, 95% CI: 0.481–0.901; P = 0.009) and major cardiovascular events (HR: 0.772, 95% CI: 0.621–0.959; P = 0.019). Important adverse events, primarily infections and abnormal blood pressure, were comparable between the two groups. Adding hemoadsorption significantly reduced all-cause mortality, cardiovascular mortality, and major cardiovascular events compared to HD alone (mainly low-flux HD plus intermittent HDF). Trial Registration: ClinicalTrials.gov NCT03227770. This randomized open-label trial shows that hemoadsorption combined with hemodialysis reduces all-cause and cardiovascular mortality, and cardiovascular events in patients with end-stage kidney disease compared to hemodialysis (mainly low-flux hemodialysis plus intermittent hemodiafiltration) alone.

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