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Abstract: TH-PO235

Effects of Targeting 11 to 13 g/dL of Hb on Renal Outcome in Non-Diabetic Patients with Advanced CKD: A Randomized Control Study, PREDICT

Session Information

Category: Anemia and Iron Metabolism

  • 202 Anemia and Iron Metabolism: Clinical


  • Imai, Enyu, Nakayamadera Imai Clinic, Takarazuka, Japan
  • Hayashi, Terumasa, Osaka General Medical Center, Osaka, Japan
  • Maruyama, Shoichi, Nagoya University Graduate School of Medicine, Nagoya, Japan
  • Narita, Ichiei, Niigata University, Niigata, Japan
  • Hirakata, Hideki, Fukuoka Renal Clinic, Fukuoka City, Japan
  • Tanabe, Kenichiro, Foundation for Biomedical Research and Innovation at Kobe, Kobe, Japan
  • Morita, Satoshi, Kyoto University, Kyoto, Japan
  • Nangaku, Masaomi, the University of Tokyo School of Medicine, Tokyo, Japan
  • Tsubakihara, Yoshiharu, Graduate School of Health Care Science, Jikei Institute, Yodogawa-ku, Osaka, Japan
  • Akizawa, Tadao, Showa University School of Medicine, Tokyo, Japan

Anemia, a common complication of chronic kidney disease (CKD) is associated with high mortality. Target hemoglobin (Hb) levels using erythropoiesis stimulating agent for CKD remain controversial between 10 and 12g/dL, especially in non-diabetic patients with CKD.


The open-label randomized controlled trial, PREDICT, aims to study the impact of targeting Hb levels of 11–13 g/dL using darbepoetin alfa with reference to a low Hb target of 9–11 g/dL. The primary outcome is a renal composite endpoint (starting chronic dialysis, kidney transplantation, eGFR 6 mL/min/1.73m2 or less, and 50% decrease in eGFR).


The study enrolled 479 non-diabetic Japanese patients with eGFR 8–20 mL/min/1.73m2. Of the 479 patients evaluated, 239 were assigned to maintain high Hb and 240 were assigned to maintain low Hb. Mean Hb level reached at 11.0g/dL at 16 week in high Hb group and maintained at 11.1g/dl during the study, while it was maintained at 10.0 g/dL in low Hb group. Mean doses of darbepoetin alfa in high and low Hb groups were 317 and 185μg/12 weeks, respectively. The renal composite endpoint occurred 105 (43.9%) in high Hb group and 116 (48.3%) in low Hb group (p=0.315 for log-rank test, Cox HR 0.78, p=0.075). Mean GFR reduction rate from baseline was significantly lower in high Hb group than in low Hb group at 24 week (-3.1 vs -11.0 %, p=0.001), 48 week (-11.0 vs -17.6 %, p=0.016), and 72 week (-9.34 vs -18.3%, p=0.024). Cardiovascular events occurred in 19 patients (7.9%) assigned to high Hb group and in 16 patients (6.7%) to low Hb group (HR 1.07, p=0.841). All cause death occurred 14 patients (5.9%) in high Hb group and 11 patients (4.6%) in low Hb group (HR 1.28, p=0.561).


Maintaining Hb at 11-13g/dL compared with Hb 9-11 g/dL by use of darbepoetin alfa did not improve renal outcome in patients with advanced CKD without diabetes, while it did not exacerbate cardiovascular outcome or all cause death.
( No. NCT01581073).


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