Kidney Week

Abstract: PUB123

A Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of FX CorAL Dialyzers during Hemodialysis Treatment in Chinese Patients on Maintenance Hemodialysis: Study Protocol

Session Information

• Publication Only

Category: Dialysis

• 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

• Gan, Liangying, Peking University People's Hospital, Beijing, China

Liangying Gan, MD

• Zhao, Bingbin, Fresenius Medical Care, Beijing, China

Bingbin Zhao, MD

• Zhang, Lily, Fresenius Medical Care, Beijing, China

Lily Zhang

• Guo, Yuanying, Fresenius Medical Care, Shanghai, China

Yuanying Guo, MPH

• Lin, Qing, Fresenius Medical Care, Beijing, China

Qing Lin

• Griesshaber, Bettina, Fresenius Medical Care, Bad Homburg, Germany

Bettina Griesshaber, PhD

• Ho, Kakiu, Fresenius Medical Care, Hong Kong, China

Kakiu Ho

• Stauss-Grabo, Manuela, Fresenius Medical Care, Bad Homburg, Germany

Manuela Stauss-Grabo, PhD

• Zuo, Li, Peking University People's Hospital, Beijing, China

Li Zuo, MD

Background

Dialyzers are designed to eliminate uremic toxins during dialysis treatment, this is especially important as the accumulation of small and middle molecular weight uremic solutes is associated with increased morbidity and mortality. The FX CorAL dialyzers are a series of high flux hemodialyzers with a modified membrane surface, resulting in improved clearance performance and hemocompatibility. This study tests the hypothesis of non-inferiority of efficacy and safety comparing FX CorAL to WEGO dialyzer.

Methods

In the two-stage, prospective, multicenter, randomized, parallel controlled, open, non-inferior study, a total of 238 adult Chinese maintenance hemodialysis patients will be enrolled and randomized in a 1:1 fashion to the investigational group (FX CorAL, Fresenius Medical Care AG) and the control group (WEGO HF, Shandong Weigao Blood Purification Products, China). Each patient will undergo regular thrice weekly HD treatment. The study consists of two mid-week HD treatments in sequence for study dialyzer evaluations (Stage I with surface area 1.4 m²: FX CorAL 60 vs. WEGO HF14; Stage II with surface area 1.8 m²: FX CorAL 80 vs. WEGO HF18), and a washout period including two HD treatments between Stage I and II (figure 1). The primary endpoints are clearance of creatinine and urea nitrogen at 60 min after start of dialysis, and reduction ratio of β2-microglobulin during HD treatment. The secondary endpoints include removing performance of other uremic solutes, inflammatory markers, and safety.

Results

The study is ongoing and will be completed in 2027.

Conclusion

This study will add insights to the efficacy and safety profiles for FX CorAL dialyzer. It is hypothesized that the uremic toxin clearance performance of FX CorAL is non-inferior (and potentially superior) to the comparator dialyzer.

Figure1. Study flowchart.

Funding

• Commercial Support – Fresenius Medical Care