Kidney Week

Abstract: SA-PO328

A Novel Potassium Binder Sodium Zirconium Cyclosilicate to Enable RAAS Inhibitor (RAASi) Use in the Treatment of Patients with Diabetic Kidney Disease: The Crystal Study

Session Information

• Diabetic Kidney Disease: Clinical Pathology, Diagnostic and Treatment Advances
  October 26, 2024 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Diabetic Kidney Disease

• 702 Diabetic Kidney Disease: Clinical

Authors

• Wang, Weiming, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China

Weiming Wang, MD

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

Leyi Gu, MD, PhD

• Zang, Xiujuan, Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China

Xiujuan Zang, MD

• Liu, Na, Tongji University Dongfang Hospital, Shanghai, Shanghai, China

Na Liu, MD

• Pan, Yangbin, Shanghai Pudong Hospital, Shanghai, Shanghai, China

Yangbin Pan, PhD

• Jiang, Chunming, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China

Chunming Jiang, CNS

• Li, Ying, Shanghai Jiading Hospital, Shanghai, Shanghai, China

Ying Li, MD

• Jiang, Gengru, Shanghai Jiaotong University School of Medicine Xinhua Hospital, Shanghai, Shanghai, China

Gengru Jiang, MD, DrPH

• Mao, Zhiguo, Shanghai Changzheng Hospital, Shanghai, Shanghai, China

Zhiguo Mao, MD, PhD

• Xue, Jun, Huashan Hospital Fudan University, Shanghai, Shanghai, China

Jun Xue, MD, PhD

• Zhou, Rong, Shanghai Yangpu District Central Hospital, Shanghai, Shanghai, China

Rong Zhou, MD, PhD

• Xu, Hao, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China

Hao Xu

• Liu, Jian, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China

Jian Liu, MD

Background

The key treatment strategy for diabetic kidney disease (DKD) involves optimizing the comprehensive management of blood glucose, blood pressure and proteinuria. Renin-angiotensin-aldosterone system inhibitors (RAASis) are preferred due to their effectiveness in lowering blood pressure, reducing urine protein and slowing kidney damage progression. However, RAASi may cause hyperkalemia (HK) in DKD patients, and RAASi reduction or discontinuation due to HK will affect its cardio-renal benefits. Therefore, it is crucial for DKD patients to receive RAASi at target dose while simultaneously managing hyperkalemia.

Methods

This is a multicenter, open-label, randomized clinical study to evaluate the efficacy of sodium zirconium cyclosilicate (SZC) in enabling RAASi usage in DKD patients (stage 3-4 chronic kidney disease). Patients are eligible if they experienced HK (sK>5.0 mmol/L) at least once in the 90 days prior to enrollment. Eligible patients will be randomized 1:1 to enter the SZC + RAASi or RAASi-only group and were followed up for 24 weeks, including a 12-week RAASi titration phase and a 12-week ACEIs/ARBs maintenance therapy phase. The primary endpoint is the proportion of patients with increased dose of RAASi at week 12. The exploratory endpoints include the distribution of patients with ≥50% of labelled maximum dose of RAASi and changes in UACR, serum creatinine and blood pressure at weeks 12 and 24.

Results

The CRYSTAL study has achieved 100% enrollment as of 2023 Dec, enrolling 86 patients with RAASi treatment. Results for the primary endpoint have been collected by March 2024 (week 12) and all follow-up data will be generated by June 2024 Jun (week 24). These results will be presented at the 2024 ASN congress.

Conclusion

This study will provide the first evidence on how SZC optimizes RAASi treatment while controlling hyperkalemia in the Chinese population.

Funding

• Commercial Support – AstraZeneca China