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Kidney Week

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

Authors

  • 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
Background


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.

Methods


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).

Results


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).

Conclusion


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.
(ClinicalTrials.gov No. NCT01581073).

Funding

  • Private Foundation Support