Kidney Week

Abstract: TH-PO1256

Telitacicept for IgA Nephropathy: Final Two-Year Results of the Phase 3 TELIGAN Trial

Session Information

• Late-Breaking Research Posters
  October 22, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

• 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

• Lv, Jicheng, Peking University First Hospital, Beijing, China

Jicheng Lv, MD

• Liu, Lijun, Peking University First Hospital, Beijing, China

Lijun Liu, MD

• Tang, Sydney, Division of Nephrology, Department of Medicine, School of Clinical Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong, China

Sydney Tang, MD, MBBS, PhD

• Wang, Wenxiang, RemeGen Co., Ltd, Yantai, Shandong, China

Wenxiang Wang, MD

• Reich, Heather N., Division of Nephrology, University Health Network, Department of Medicine, University of Toronto, Toronto, Ontario, Canada

Heather N. Reich, MD, PhD

• Li, Lin, RemeGen Co., Ltd, Yantai, Shandong, China

Lin Li, PhD

• Mao, Weihong, RemeGen Co., Ltd, Yantai, Shandong, China

Weihong Mao

• Zhang, Yifan, RemeGen Co., Ltd, Yantai, Shandong, China

Yifan Zhang, MD

• Fang, Jianmin, RemeGen Co., Ltd, Yantai, China

Jianmin Fang, PhD

• Perkovic, Vlado, University of New South Wales, Sydney, New South Wales, Australia

Vlado Perkovic, MBBS, PhD, FASN

• Zhang, Hong, Peking University First Hospital, Beijing, China

Hong Zhang, MD, PhD

Background

Dual inhibition of B-lymphocyte stimulator (BAFF) and a proliferation-inducing ligand (APRIL) targets the underlying pathogenesis of IgA nephropathy. We report the 2-year efficacy, biomarker, and safety endpoints from the phase 3 TELIGAN trial.

Methods

Patients with IgA nephropathy were randomized to telitacicept (240 mg) or placebo once weekly through week 39, then a maintenance regimen of 240 mg every 2 weeks through week 104. The primary endpoint was the annualized estimated glomerular filtration rate (eGFR) slope over 104 weeks. Other key endpoints included confirmed eGFR decline of ≥ 30% and ≥ 40%, composite kidney events (kidney failure or related death), 24-hour UPCR changes, serum Gd-IgA1 levels. Safety was also evaluated.

Results

Overall 318 patients were randomized (159 per group). The 2-year annualized eGFR slope was -0.6 ml/min/1.73 m²/year with telitacicept vs. -5.7 ml/min/1.73 m²/year with placebo (between-group difference, 5.1 ml/min/1.73 m²/year; 95% confidence interval [CI], 3.5 to 6.7; P<0.001). Confirmed eGFR decline of ≥ 30% occurred in fewer patients with telitacicept than placebo (2.5% vs. 16.4%, HR 0.11, 95% CI, 0.04 to 0.30）, as did ≥ 40% (2.5% vs 9.4%, HR 0.19, 95% CI, 0.06 to 0.56) and composite kidney failure events (0% vs 3.1%). At week 104, the placebo-adjusted UPCR GMR was 0.39 (60.7% reduction; 95% CI, 52.6% to 67.4%), and serum Gd-IgA1 levels changed by -47.8% in the telitacicept group vs. 19.1% with placebo. Adverse events occurred in 95.0% with telitacicept vs. 89.3% with placebo. Rates of serious adverse events (8.2% vs. 18.2%), serious infection (1.9% vs 4.4%) and overall infection (67.3% vs. 67.3%) were not increased with telitacicept. No deaths occurred.

Conclusion

Treatment with telitacicept significantly reduced decline in kidney function compared to placebo with a favorable long-term safety profile.

Funding

• Commercial Support – RemeGen Co., Ltd