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Abstract: PO2499

The Effect of Anemia Correction with ESA and Cholecalciferol Supplementation on Post-Transplant Malignancy Among Kidney Transplant Recipients: A Prespecified Analysis of a Randomized Clinical Trial

Session Information

Category: Transplantation

  • 1902 Transplantation: Clinical

Authors

  • Obi, Yoshitsugu, The University of Tennessee Health Science Center College of Medicine, Memphis, Tennessee, United States
  • Ichimaru, Naotsugu, Osaka Daigaku Daigakuin Igakukei Kenkyuka Igakubu, Suita, Osaka, Japan
  • Isaka, Yoshitaka, Osaka Daigaku Daigakuin Igakukei Kenkyuka Igakubu, Suita, Osaka, Japan
  • Hamano, Takayuki, Osaka Daigaku Daigakuin Igakukei Kenkyuka Igakubu, Suita, Osaka, Japan

Group or Team Name

  • The CANDLE-KIT Trial Investigators
Background

Kidney transplant recipients (KTRs) are at increased risk of cancer, and post-transplant malignancy (PTM) is among the leading causes of death with functioning allograft. Aggressive anemia correction with ESA slows the rate of decline in kidney allograft function but may increase the incidence of PTM. Vitamin D is proposed to exert pleiotropic effects including anti-cancer properties and may prevent the development of PTM.

Methods

We enrolled 153 KTRs with anemia and >1-year history of transplantation across 23 facilities in Japan and conducted a multicenter, two-by-two factorial, open-label, randomized clinical trial. Patients were randomly assigned to either a high or low hemoglobin (Hb) target (>12.5 vs <10.5 g/dL) and to either cholecalciferol 1000 IU/day or control. PTM was a prespecified secondary outcome.

Results

Patients were 51±12 years-old, among whom 54% were male. The median (IQR) of transplant vintage was 8 (5, 12) years. Their baseline eGFR, Hb, and serum 25(OH)D levels were 30.6±11.0 mL/min per 1.73 m2, 10.7±1.2 g/dL, and 14.5±5.2 ng/mL, respectively. There was no between-group difference in the prevalence of prior malignancy in either arm. The mean Hb level was 11.4 g/dL and 10.6 g/dL in the high and low Hb target groups, respectively. The mean serum 25(OH)D level exceeded 30 ng/mL in the cholecalciferol group after Month 6 whereas it did not change in the control group throughout the study period. A total of 7 PTMs developed during 2 years of the follow up; 2 lung cancers, 1 breast cancer, 1 gastric cancer, 1 testicular cancer, 1 renal cell carcinoma, and 1 myelodysplastic syndrome. There was no between-group difference in the incidence of PTM in the hemoglobin target arm (i.e., n=3 [4.1%] vs. 4 [5.1%] in the high vs. low Hb target group, respectively; P=0.77). In the cholecalciferol arm, all 7 PTMs developed in the control group while none was observed in the cholecalciferol group (i.e., 9.1% vs. 0%, respectively; P=0.007).

Conclusion

The incidence of PTM was not increased by aggressive anemia correction with ESA and was reduced by cholecalciferol supplementation among KTRs. Large clinical trials with a long-follow up period are needed to validate these findings. Registered at ClinicalTrials.gov (NCT01817699).

Funding

  • Commercial Support – Chugai, Kissei, Roche Diagnostic K.K.