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Abstract: TH-PO237

Renal Outcome by Different Target Hemoglobin Levels Using Epoetin Beta Pegol in Predialysis CKD Patients with ESA Hyporesponsiveness: A Multicenter Open-Label Randomized Controlled Study (RADIANCE-CKD)

Session Information

Category: Anemia and Iron Metabolism

  • 202 Anemia and Iron Metabolism: Clinical

Authors

  • Hayashi, Terumasa, Osaka General Medical Center, Osaka, Japan
  • Yamamoto, Hiroyasu, Division of Nephrology and Hypertension, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan
  • Tsuruya, Kazuhiko, Nara Medical University, Kashihara, Japan
  • Hase, Hiroki, Toho University Ohashi Medical Center, Tokyo, Japan
  • Nishi, Shinichi, Kobe University Graduate School of Medicine, Kobe, Japan
  • Yamagata, Kunihiro, University of Tsukuba, Tsukuba, Japan
  • Nangaku, Masaomi, the University of Tokyo School of Medicine, Tokyo, Japan
  • Wada, Takashi, Kanazawa University, Ishikawa, Japan
  • Uemura, Yukari, Tokyo University Hospital, Tokyo, Japan
  • Ohashi, Yasuo, University of Tokyo, Tokyo, Japan
  • Hirakata, Hideki, Fukuoka Renal Clinic, Fukuoka City, Japan
Background

Although ESA hyporesponsiveness has emerged with respect to a poor renal and overall survival in CKD patients, appropriate ESA treatments to patients with ESA hyporesponsiveness remain uncertain.

Methods

We randomly assigned 362 predialysis CKD patients with ESA hyporesponsiveness to the intensive treatment group (target hemoglobin [Hb] level ≧ 11g/dl) and conservative treatment group (target Hb level; baseline Hb levels ± 1g/dl) using epoetin beta pegol (CERA). The primary renal composite endpoint was a transition to renal replacement therapy, a reduction of eGFR to less than 6ml/min/1.73m2 or a reduction of eGFR more than 30%. The observation period was 21 months from the assignment.

Results

Mean age was 74.7 years and 58.6% were male. Mean baseline eGFR in the intensive and conservative groups were 15.3 and 15.9ml/min/1.73m2, respectively. Mean baseline hemoglobin level was similar of 9.9g/dl in both groups despite an appropriate and similar median dose of ESA (86 and 100 μg/month for CERA, P 0.913; 120 and 80 μg/month for darbepoetin alfa, P 0.136, respectively). Mean Hb levels during observation period in each group were 10.44 and 10.05 g/dl (P < 0.0001) and median doses of CERA were 120.0 and 96.3 μg/month, respectively (P < 0.0001). Kaplan-Meier analysis showed no significant difference in the primary end point between the two groups (99 and 109 events; log-rank test, P 0.837). Cox proportional hazards analysis also showed no significant difference between the two groups (Hazard ratio, 0.972; 95% confidence interval, 0.74 to 1.28; P = 0.84. The incidence of cardiovascular events (CVEs) was not different in both groups [20 (10.9%) and 24 (13.4%) patients, respectively (P 0.522)]. Heart failure accounted for approximately 65% of CVEs in both groups.

Conclusion

Although there was no significant difference in renal outcome, our results suggest that targeting Hb level of 11g/dl or higher using CERA may be safe in terms of CVEs in predialysis Japanese CKD patients with ESA hyporesponsiveness. This study is funded by Chugai Pharmaceutical Co., Ltd.

Funding

  • Commercial Support