Kidney Week

Abstract: FR-PO1080

Effects of Sodium Zirconium Cyclosilicate on Quality of Life in Patients Undergoing Hemodialysis with Hyperkalemia: Design and Rationale of the Y-QOL Study

Session Information

• Kidney Nutrition and Metabolism
  October 25, 2024 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Health Maintenance, Nutrition, and Metabolism

• 1500 Health Maintenance, Nutrition, and Metabolism

Authors

• Wakui, Hiromichi, Yokohama Shiritsu Daigaku Igakubu Daigakuin Igaku Kenkyuka, Yokohama, Kanagawa, Japan

Hiromichi Wakui, MD, PhD

• Kanai, Daisuke, Yokohama Shiritsu Daigaku Igakubu Daigakuin Igaku Kenkyuka, Yokohama, Kanagawa, Japan

Daisuke Kanai, MD

• Yoshimura, Shiori, Yokohama Shiritsu Daigaku Igakubu Daigakuin Igaku Kenkyuka, Yokohama, Kanagawa, Japan

Shiori Yoshimura, MD

• Hanaoka, Masaaki, Yokohama Shiritsu Daigaku Igakubu Daigakuin Igaku Kenkyuka, Yokohama, Kanagawa, Japan

Masaaki Hanaoka, MD

• Mitsuhashi, Hiroshi, Yokohama Shiritsu Daigaku Igakubu Daigakuin Igaku Kenkyuka, Yokohama, Kanagawa, Japan

Hiroshi Mitsuhashi

• Kawano, Tomoyuki, Yokohama Shiritsu Daigaku Igakubu Daigakuin Igaku Kenkyuka, Yokohama, Kanagawa, Japan

Tomoyuki Kawano

• Katsumata, Mari, Yokohama Shiritsu Daigaku Igakubu Daigakuin Igaku Kenkyuka, Yokohama, Kanagawa, Japan

Mari Katsumata

• Yamaguchi, Satoshi, Yokohama Shiritsu Daigaku Igakubu Daigakuin Igaku Kenkyuka, Yokohama, Kanagawa, Japan

Satoshi Yamaguchi, MD

• Ogawa, Nariaki, Yokohama Shiritsu Daigaku Igakubu Daigakuin Igaku Kenkyuka, Yokohama, Kanagawa, Japan

Nariaki Ogawa, MD

• Ohsawa, Masato, Yokohama Shiritsu Daigaku Igakubu Daigakuin Igaku Kenkyuka, Yokohama, Kanagawa, Japan

Masato Ohsawa, MD, PhD

• Okami, Naohito, Yokohama Shiritsu Daigaku Igakubu Daigakuin Igaku Kenkyuka, Yokohama, Kanagawa, Japan

Naohito Okami

• Taguchi, Shinya, Yokohama Shiritsu Daigaku Igakubu Daigakuin Igaku Kenkyuka, Yokohama, Kanagawa, Japan

Shinya Taguchi, MD, PhD

• Kinguchi, Sho, Yokohama Shiritsu Daigaku Igakubu Daigakuin Igaku Kenkyuka, Yokohama, Kanagawa, Japan

Sho Kinguchi, MD

• Azushima, Kengo, Yokohama Shiritsu Daigaku Igakubu Daigakuin Igaku Kenkyuka, Yokohama, Kanagawa, Japan

Kengo Azushima, MD, PhD

• Kuji, Tadashi, Yokohama Shiritsu Daigaku Igakubu Daigakuin Igaku Kenkyuka, Yokohama, Kanagawa, Japan

Tadashi Kuji, MD, PhD

• Tamura, Kouichi, Yokohama Shiritsu Daigaku Igakubu Daigakuin Igaku Kenkyuka, Yokohama, Kanagawa, Japan

Kouichi Tamura, MD, DrMed, PhD

Background

Patients undergoing hemodialysis (HD) experience inadequate control of fluid and electrolyte balance through dialysis alone, requiring stringent dietary restrictions. This negatively impacts the quality of life (QOL), which is markedly lower in chronic kidney disease (CKD) patients on dialysis compared to healthy individuals. Moreover, reduced QOL has been linked to poorer prognosis in patients on maintenance dialysis. Hyperkalemia, a common issue in these patients, significantly correlates with increased mortality and necessitates strict dietary potassium restrictions, further diminishing QOL. Traditional potassium binders, like calcium and sodium polystyrene sulfonate, are limited by frequent dosing requirements and adverse effects. Sodium zirconium cyclosilicate (SZC) presents a promising alternative, offering effective potassium removal from the gut with minimal impact on other electrolytes and reduced dosing frequency. This study evaluates whether SZC treatment improves QOL by easing dietary potassium restrictions in patients undergoing HD.

Methods

The Y-QOL study is an 8-week, multicenter, randomized, parallel-group, open-label trial. It plans to enroll 200 hyperkalemic outpatients (potassium levels 5.5 to 6.4 mEq/L after a 2-day inter-dialytic interval) undergoing regular thrice-weekly HD. Participants will be randomized to either receive daily SZC (starting at 5 g on non-dialysis days, with potential adjustments up to 15 g based on serum potassium levels) plus dietary guidance, or to a control group receiving only dietary guidance aimed at maintaining serum potassium levels between 4.0 and 5.4 mEq/L. The primary endpoint is changes in QDIS-7 scores at Week 8 from baseline in the intervention group and control group, respectively.

Results

The recruitment of the first participants commenced on January 24, 2024. As of May 2024, 28 participants have been enrolled. The study is projected to conclude on March 31, 2026.

Conclusion

The Y-QOL study aims to determine the effectiveness of SZC in improving QOL concerning dietary potassium intake restrictions in patients undergoing hemodialysis with hyperkalemia.

Funding

• Commercial Support –  AstraZeneka K.K.