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Kidney Week

Abstract: TH-PO1250

Telitacicept in Patients with Refractory IgA Nephropathy: A Randomized, Open-Label Clinical Trial

Session Information

Category: CKD (Non-Dialysis)

  • 2202 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

  • Liu, Shang, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital, Shanghai, China
  • Cai, Hong, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital, Shanghai, China
  • Yan, Jiayi, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital, Shanghai, China
  • Gu, Leyi, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital, Shanghai, China
  • Mou, Shan, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital, Shanghai, China
  • Wang, Qin, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital, Shanghai, China
Background

Refractory IgA nephropathy has poor prognosis with limited therapies. Telitacicept inhibits BLyS/APRIL for autoimmune rheumatic diseases. This investigator-initiated trial evaluated its efficacy and safety in refractory IgAN.

Methods

63 patients from 4 renal centers received 24-week treatment, randomized to telitacicept plus supportive care (36 patients) or supportive care alone (27 patients). Primary endpoint: relative reduction in 24-h proteinuria; secondary endpoints: adverse events, eGFR, urine protein-creatinine ratio.

Results

18/36 TTXP patients achieved complete or partial remission. At week 24, proteinuria decreased by 48.09% from baseline in the TTXP arm, while proteinuria remained unchanged in controls. Renal function differed significantly between groups: eGFR changed +1.27% (95% CI −5.46, 9.30) in the TTXP group versus −10.19% (95% CI −18.33, 1.20) in controls (P=0.001). Among patients with moderate-severe renal injury, telitacicept reduced proteinuria by 31.87% at week 12 and 45.95% at week 24. The Oxford MEST-C NOS+Adh+ subgroup showed a trend toward better clinical response. Adverse event rates were similar in both groups.

Conclusion

Telitacicept delivers superior proteinuria-lowering efficacy with matched safety versus supportive care, offering a promising new therapy for refractory IgA nephropathy.