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

• Anemia and Iron Metabolism: Clinical
  October 25, 2018 | Location: Exhibit Hall, San Diego Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Anemia and Iron Metabolism

• 202 Anemia and Iron Metabolism: Clinical

Authors

• Imai, Enyu, Nakayamadera Imai Clinic, Takarazuka, Japan

Enyu Imai,

• Hayashi, Terumasa, Osaka General Medical Center, Osaka, Japan

Terumasa Hayashi,

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

Shoichi Maruyama,

• Narita, Ichiei, Niigata University, Niigata, Japan

Ichiei Narita,

• Hirakata, Hideki, Fukuoka Renal Clinic, Fukuoka City, Japan

Hideki Hirakata,

• Tanabe, Kenichiro, Foundation for Biomedical Research and Innovation at Kobe, Kobe, Japan

Kenichiro Tanabe,

• Morita, Satoshi, Kyoto University, Kyoto, Japan

Satoshi Morita,

• Nangaku, Masaomi, the University of Tokyo School of Medicine, Tokyo, Japan

Masaomi Nangaku,

• Tsubakihara, Yoshiharu, Graduate School of Health Care Science, Jikei Institute, Yodogawa-ku, Osaka, Japan

Yoshiharu Tsubakihara,

• Akizawa, Tadao, Showa University School of Medicine, Tokyo, Japan

Tadao Akizawa,

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