Efficacy and safety of patiromer for hyperkalemia: a randomized, placebo-controlled phase 3 study.

IF 2.2 4区医学 Q2 UROLOGY & NEPHROLOGY

Clinical and Experimental Nephrology Pub Date : 2025-02-20 DOI:10.1007/s10157-025-02637-4

Naoki Kashihara, Hirokazu Okada, Yusuke Suzuki, Tamio Iwamoto, Masashi Yasutomi, Masaru Matsui, Ryo Takezawa, Takayuki Ishii, Yusuke Tomioka

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Abstract

Background: This is the phase 3 study in Japan designed to verify the superiority of patiromer over placebo using the change in serum potassium level (sK-level).

Methods: This study was a multicenter, randomized withdrawal study targeting Japanese hyperkalemic patients. It consisted of the run-in period and the double-blind period. The run-in period was an active single-arm, open-label period (4 or 5 weeks). The double-blind period was a randomized, placebo-controlled, parallel-group, double-blind period (4 weeks). Patients whose sK-level was within the normal range at week 4 or 5 of the run-in period entered the double-blind period. Patients who entered the double-blind period were randomly assigned to the patiromer group or the placebo group.

Results: As a result of the primary analysis, the change of the sK-level (95% CI) from baseline to week 4 in the double-blind-period, was - 0.02 (- 0.19, 0.15) mmol/L in the patiromer group, and 0.78 (0.60, 0.96) mmol/L in the placebo group, with a statistically significant difference between the two treatment groups (p < 0.001). Similarly, statistically significant differences were also observed between the two groups at weeks 1, 2, and 3. Furthermore, the proportion of patients whose sK-level was maintained within the normal range were statistically significantly higher in the patiromer group than in the placebo group at all time points. No adverse events requiring particular attention were observed.

Conclusion: Patiromer can improve hyperkalemia by lowering sK-level and can suppress the recurrence of hyperkalemia with continued administration, and is safe and easy-to-use for a wide range of patients.

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来源期刊

Clinical and Experimental Nephrology UROLOGY & NEPHROLOGY-

CiteScore

4.10

自引率

4.30%

发文量

135

审稿时长

4-8 weeks

期刊介绍： Clinical and Experimental Nephrology is a peer-reviewed monthly journal, officially published by the Japanese Society of Nephrology (JSN) to provide an international forum for the discussion of research and issues relating to the study of nephrology. Out of respect for the founders of the JSN, the title of this journal uses the term “nephrology,” a word created and brought into use with the establishment of the JSN (Japanese Journal of Nephrology, Vol. 2, No. 1, 1960). The journal publishes articles on all aspects of nephrology, including basic, experimental, and clinical research, so as to share the latest research findings and ideas not only with members of the JSN, but with all researchers who wish to contribute to a better understanding of recent advances in nephrology. The journal is unique in that it introduces to an international readership original reports from Japan and also the clinical standards discussed and agreed by JSN.