Kidney Week

Abstract: TH-PO240

A Randomized Trial of Middle Molecule Clearance in Patients on Chronic Hemodialysis: Results from the ROCKeT Study

Session Information

• Hemodialysis, Hemodiafiltration, and Frequent Dialysis
  October 24, 2024 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Dialysis

• 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

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

Li Zuo, MD

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

Liangying Gan, MD

• Gu, Leyi, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital, Shanghai, Shanghai, China

Leyi Gu, MD, PhD

• Ge, Yongchun, General Hospital of Eastern Theatre Command, Nanjing, Jiangsu, China

Yongchun Ge, MD

• Lin, Hong Li, First Affiliated Hospital of Dalian Medical University, Dalian, Dalian, China

Hong Li Lin, MD

• Li, Yiwen, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China

Yiwen Li

• Chen, Fengling, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China

Fengling Chen

• Li, Wenge, China-Japan Friendship Hospital, Beijing, Beijing, China

Wenge Li

• Gao, Bi hu, Affiliated Zhongshan Hospital of Dalian University, Dalian, Liaoning, China

Bi hu Gao, MD

• Ding, Feng, Shanghai Jiao Tong University School of Medicine Affiliated Ninth People's Hospital, Shanghai, China

Feng Ding

• Zhang, Xinzhou, Shenzhen People's Hospital, Shenzhen, Guangdong, China

Xinzhou Zhang

• Shi, Zhenwei, Beijng Huaxin Hospital First Hospital of Tsinghua University, Beijing, China

Zhenwei Shi

• Ji, Jiayao, Baxter Healthcare Corporation, Round Lake, Illinois, United States

Jiayao Ji

• Yao, Qiang, Baxter Healthcare Corporation, Round Lake, Illinois, United States

Qiang Yao, MD, PhD

• Keller, Brad, Baxter Healthcare Corporation, Round Lake, Illinois, United States

Brad Keller, MS, PhD

• Sarkar, Surupa, Baxter Healthcare Corporation, Round Lake, Illinois, United States

Surupa Sarkar, MPH

Background

This study aimed to establish noninferiority of λ FLC and β2M molecular clearance with HDx therapy using Theranova 400 compared to post-dilution online HDF therapy using FX800 (control arm) in Chinese patients with kidney failure.

Methods

The clearance of λ FLC, β2M, urea, α1-MG, YKL-40, CFD, myoglobin, and κ FLC was measured using the reduction ratio (RR) of the molecule after treatment at the mid-week dialysis session. Kt/V_urea was assessed to establish dialysis adequacy. Two-sample t-tests were performed to compare the 95% CI of the difference in RRs for λ FLC and β2M in the HDx arm against predefined noninferiority margins of -3.783 and -7.848, respectively (10% of assumed mean RR). Any noninferior RRs were then tested for superiority using hierarchical testing. The safety profile of the Theranova dialyzer was also assessed.

Results

274 adult patients receiving thrice-weekly dialysis were randomized (N=138 on HDx; N=136 on HDF). No differences were observed between the arms in terms of demographics, baseline characteristics and treatment parameters. The average utilized replacement volume in the HDF arm was 17±2.4L. The RR of λ FLC in the HDx arm was both noninferior and superior to the HDF arm; ΔRR=17.0% (14.8%,19.2%). The RR of β2M in the HDx arm was noninferior to the HDF arm; ΔRR=-1.2% (-2.5%,0.2%). Overall, Kt/V_urea and urea RRs were similar between the arms (p=0.37 and p=0.45, respectively). The HDx arm had significantly higher clearance of α1-MG, YKL-40, CFD, myoglobin, and κ FLC than the HDF arm. No difference was observed in the incidence rate of complications between the arms (p=0.15).

Conclusion

Our study demonstrates the effectiveness of HDx theraphy in clearing multiple middle molecules when compared to HDF therapy, with no observed differences in the overall safety or efficacy of dialysis.

Funding

• Commercial Support – Baxter Healthcare Corporation