Kidney Week

Abstract: SA-OR080

Febuxostat for Patients with CKD Stage G3 with Asymptomatic Hyperuricemia: A Randomized Trial

Session Information

• New Considerations for Renoprotection Clinical Trials
  October 27, 2018 | Location: 1B, San Diego Convention Center
  Abstract Time: 04:54 PM - 05:06 PM

Category: CKD (Non-Dialysis)

• 1902 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

• Shibagaki, Yugo, St. Marianna University, Kawasaki, TOKYO, Japan

Yugo Shibagaki, MD

• Ohno, Iwao, The Jikei University School of Medicine, Tokyo, Japan

Iwao Ohno,

• Imai, Naohiko, St. Marianna University, Kawasaki, TOKYO, Japan

Naohiko Imai,

• Uchida, Shunya, Teikyo University School of Medicine , Tokyo, ToKyo, Japan

Shunya Uchida,

• Maruyama, Shoichi, Nagoya University Graduate School of Medicine, Nagoya, Japan

Shoichi Maruyama,

• Ito, Sadayoshi, Tohoku Graduate School of Medicine, Sendai Miyagi, Japan

Sadayoshi Ito,

• Makino, Hirofumi, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, OKAYAMA, Japan

Hirofumi Makino,

• Ohashi, Yasuo, University of Tokyo, Tokyo, Japan

Yasuo Ohashi,

• Hosoya, Tatsuo, The Jikei University School of Medicine, Tokyo, Japan

Tatsuo Hosoya,

• Kimura, Kenjiro, Tokyo Takanawa Hospital, Tokyo, Japan

Kenjiro Kimura,

Group or Team Name

• FEATHER Study Investigators

Background

Epidemiological and clinical studies have suggested that urate-lowering therapy may slow the progression of chronic kidney disease (CKD). However, clinical evidence is still scarce.

Methods

We conducted a randomized, double-blind, placebo-controlled trial in patients with CKD stage G3 [estimated glomerular filtration rate (eGFR) < 60 and ≧ 30 ml/min/1.73m²] with asymptomatic hyperuricemia (n = 467) at 55 sites in Japan. Participants were randomly assigned, in a 1:1 ratio, to receive febuxostat (loading daily dose: 10 mg on days 1 to 28; maintenance daily dose: 40 mg at weeks 8 to 108) or placebo. The primary endpoint was the slope (mL/min/1.73 m² per year) of the eGFR. The mean eGFR slope, time-course changes in eGFR, and serum uric acid from baseline through week 108 were measured.

Results

Among 443 patients who underwent randomization, 220 received febuxostat and 222 received placebo. No significant difference was found in the mean eGFR slope between febuxostat (0.23 ± 5.26) and placebo (-0.47 ± 4.48) (difference, 0.70 mL/min/1.73 m² per year; 95% confidence interval, -0.21 to 1.62) (Figure). A subgroup analysis revealed a significant between-group difference in the kidney function decline-suppressing effect in patients who were negative for proteinuria (difference, 1.79; 95% confidence interval, 0.55 to 3.03) and whose serum creatinine concentration was lower than the median (difference, 1.76; 95% confidence interval, 0.44 to 3.07). The incidence of gouty arthritis was significantly lower (P = 0.007) in the febuxostat group [0.91% (2/219)] than in the placebo group [5.86% (13/222)]. Adverse events specific to febuxostat did not occur.

Conclusion

Febuxostat failed to show a statistically significant renoprotective effect as compared with placebo in Japanese patients with CKD stage G3 with asymptomatic hyperuricemia.

Funding

• Commercial Support – Teijin Pharma Limited