Efficacy and Safety Analysis of Roxarestat in Regulating Renal Anemia in Patients on Maintenance Hemodialysis.

OBJECTIVE

To compare the efficacy and safety of roxarestat versus recombinant human erythropoietin (rhEPO) in the management of renal anemia in patients undergoing maintenance hemodialysis.

METHODS

This was a prospective, open-label, randomized controlled trial. A total of 240 patients were randomly assigned to receive either oral roxarestat (n = 120) or subcutaneous rhEPO (n = 120) for 6 months. The target hemoglobin (Hb) range was set at 110-130 g/L for both groups, and dose adjustments were permitted based on Hb levels during follow-up. The primary endpoint was the change in Hb level from baseline to 6 months. Secondary endpoints included changes in red blood cell (RBC) count, hematocrit (Hct), iron metabolism parameters (serum ferritin [SF], serum iron [SI], hepcidin [Hepc], transferrin [TRF], total iron binding capacity [TIBC]), inflammatory markers (tumor necrosis factor-α [TNF-α], interleukin-1β [IL-1β], interleukin-6 [IL-6]), quality of life scores (Kidney Disease Quality of Life-36 [KDQOL-36]), and the incidence of adverse events.

RESULTS

After 6 months, Hb increased from 82.13 ± 27.43 g/L to 101.3 ± 10.34 g/L in the rhEPO group and from 83.60 ± 8.29 g/L to 110.6 ± 11.00 g/L in the roxarestat group. The increase in Hb was significantly greater in the roxarestat group (mean difference 9.30 g/L, 95% CI 6.45-12.15, p < 0.001). Similarly, RBC and Hct levels were also significantly higher in the roxarestat group compared with the rhEPO group (p < 0.05 for both). Improvements in iron metabolism parameters and reductions in inflammatory markers were more pronounced in the roxarestat group. Quality of life scores improved in both groups, with significantly higher scores in the roxarestat group in all KDQOL-36 subscales (p < 0.05). The incidence of adverse events was 20.83% in the roxarestat group and 16.67% in the rhEPO group, with no statistically significant difference (p = 0.226).

CONCLUSION

Roxarestat was more effective than rhEPO in increasing hemoglobin levels and other anemia-related parameters in maintenance hemodialysis patients, with comparable safety. The findings suggest that roxarestat may offer advantages in iron metabolism modulation and inflammation reduction, contributing to improved quality of life.