Kidney Week

Abstract: FR-PO1202

Correcting Anemia and Native Vitamin D Supplementation in Kidney Transplant Recipients: A Randomized Clinical Trial

Session Information

• Transplantation: Clinical - Immunosuppression, Adherence, Outcomes
  November 08, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Transplantation

• 1902 Transplantation: Clinical

Authors

• Obi, Yoshitsugu, University of California Irvine, Orange, California, United States

Yoshitsugu Obi,

• Ichimaru, Naotsugu, Osaka University Graduate School of Medicine, Suita, Osaka, Japan

Naotsugu Ichimaru,

• Sakaguchi, Yusuke, Osaka University Graduate School of Medicine, Suita, Osaka, Japan

Yusuke Sakaguchi,

• Hamano, Takayuki, Osaka University Graduate School of Medicine, Suita, Osaka, Japan

Takayuki Hamano,

Group or Team Name

• CANDLE-KIT Trial Study Group

Background

Higher levels of hemoglobin (Hb) and serum 25(OH)D have been associated with better allograft survival among kidney transplant recipients (KTRs). Therefore, aggressive anemia correction and cholecalciferol (VD₃) supplementation may preserve allograft kidney function.

Methods

This is a multicenter, open-label, randomized clinical trial with a 2-by-2 factorial design. KTRs with anemia and >1-year history of transplantation from 23 facilities were randomly assigned to either the high or low Hb target group (>12.5 vs. <10.5 g/dL) and to either the VD₃ (1000 IU/day) or control group. The primary outcome was the 2-year change in eGFR from baseline.

Results

This trial was stopped early after a planned interim analyses using a Pocock type α-spending function (α=0.036). At that time, 153 patients had undergone randomization, and 133 were available for the intention-to-treat analysis. Mean Hb levels at Year 2 were 11.6±1.7 g/dL and 10.7±1.3 g/dL in the high and low Hb group, respectively (Figure A). The high Hb group showed a smaller decline in eGFR than the low Hb group (i.e., -1.9±5.4 vs. -4.2±6.9 ml/min/1.73 m²; P=0.032) (Figure B), which was consistent in the per-protocol analysis. Mean serum 25(OH)D levels at Year 1 were 31.9±9.1 g/dL and 14.9±6.6 ng/mL in the VD₃ and control group, respectively (Figure C). The difference in 2-year change of eGFR did not reach statistical significance between the VD₃ and control groups (i.e., -4.0±6.1 vs. -2.2±6.3 ml/min/1.73 m², respectively; P=0.10) (Figure D), but the VD₃ group showed a greater decline in the per-protocol analysis (P=0.033). VD₃ supplementation did not modify the effect of the high Hb target strategy on eGFR (P_interaction=0.74).

Conclusion

Aggressive anemia correction preserves allograft kidney function while VD₃ supplementation may accelerate the decline rate among KTRs (ClinicalTrials.gov Identifier: NCT01817699).

Funding

• Commercial Support – Chugai Pharmaceutical, Roche Diagnostics