REAL-WORLD PERFORMANCE EVALUATION OF KOREA’S FIRST DOMESTICALLY DEVELOPED HIGH-FLUX POLYETHERSULFONE DIALYZERS

 

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REAL-WORLD PERFORMANCE EVALUATION OF KOREA’S FIRST DOMESTICALLY DEVELOPED HIGH-FLUX POLYETHERSULFONE DIALYZERS

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Kyung Don
Yoo
Seong Geun Kim kimsob88@gmail.com Inje University Internal medicine Seoul Korea (Republic of) -
Kyung Don Yoo ykd9062@gmail.com Ulsan University Internal medicine Ulsan Korea (Republic of) *
Dong Eun Yoo deyoomd@gmail.com Yonsei U Clinic Hemodialysis cencer Seoul Korea (Republic of) -
Tae Hee Lee sevkid@naver.com Yonsei Pureun Medical Center Hemodialysis center Seoul Korea (Republic of) -
Dong Ki Kim dkkim73@snu.ac.kr Seoul National University Internal medicine Seoul Korea (Republic of) -
Donghyung Lee sheon04@nate.com Beomil Yonsei Clinic Hemodialysis center Busan Korea (Republic of) -
 
 
 
 
 
 
 
 
 

As the hemodialysis population continues to rise in Korea, the heavy socioeconomic burden of imported dialyzers has become a growing concern. To address this issue, a new polyethersulfone (PES)-based dialyzer was developed domestically. The Synoflux® Series, a newly developed dialyzer, was evaluated for its clinical efficacy and safety compared with an existing dialyzer.

This multicenter, randomized, crossover, open-label study enrolled 25 patients on thrice-weekly hemodialysis. Participants received either Synoflux followed by ELISIO or vice versa, each for 6 weeks. The primary endpoint was urea reduction ratio (URR) at week 6. Secondary endpoints included small- (BUN, creatinine, phosphorus, potassium) and middle-molecule (β2-microglobulin, myoglobin, cystatin C, prolactin, α1-microglobulin, vitamin B12, interleukin-6) removal ratios, laboratory parameters, and safety outcomes such as serum albumin preservation, complement activation, and adverse events.

Twenty-four patients completed the study. Synoflux was non-inferior to ELISIO in URR (70.4% vs. 71.2%, mean difference –0.8%, 95% CI –2.4 to 0.8). Small-molecule clearance was similar between groups. Synoflux achieved significantly greater cystatin C removal (27.6% vs. 26.6%, p=0.032) and showed relatively higher removal of myoglobin and prolactin. Albumin loss was lower with Synoflux (–3.7%) compared with ELISIO (–6.1%), with no clinically significant hypoalbuminemia observed. Complement activation patterns indicated immunologic stability, and adverse events were comparable across groups.

Synoflux® Series demonstrated non-inferior dialysis adequacy and safety compared with ELISIO® Series, with potential advantages in middle-molecule clearance and albumin preservation. These findings support Synoflux as a safe and effective domestically manufactured dialyzer.

Kewords