Kidney Week

Abstract: TH-PO1252

Long-Term Efficacy and Safety of Iptacopan in Patients with IgA Nephropathy

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

• Rovin, Brad, The Ohio State University Wexner Medical Center, Columbus, Ohio, United States

Brad Rovin, MD, FASN

• Trimarchi, Hernan, Hospital Britanico de Buenos Aires, Buenos Aires, Argentina

Hernan Trimarchi, MD, PhD, FASN

• Maes, Bart D., AZ Delta, Roeselare, Belgium

Bart D. Maes, MD, PhD

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

Vlado Perkovic, MBBS, PhD, FASN

• Kashihara, Naoki, Kawasaki Medical School, Okayama, Japan

Naoki Kashihara, MD, PhD

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

Hong Zhang, MD, PhD

• Barratt, Jonathan, The Mayer IgA Nephropathy Laboratories, University of Leicester, Leicester, United Kingdom

Jonathan Barratt, MBChB, PhD

• Petrovic-Bulatovic, Katarina, Novartis Pharma AG, Basel, BS, Switzerland

Katarina Petrovic-Bulatovic, PhD

• Attari, Zenab, Novartis Healthcare Private Limited Hyderabad, Hyderabad, Telangana, India

Zenab Attari, PhD

• Jacinto-Sanders, Severina, Novartis Pharma AG, Basel, BS, Switzerland

Severina Jacinto-Sanders, PhD

• Magirr, Annabel Rose, Novartis Pharma AG, Basel, BS, Switzerland

Annabel Rose Magirr, MS

• Renfurm, Ronny, Novartis Pharma AG, Basel, BS, Switzerland

Ronny Renfurm, MD, MBA

• Hach, Thomas, Novartis Pharma AG, Basel, BS, Switzerland

Thomas Hach, MD

• Rizk, Dana V., University of Alabama at Birmingham, Birmingham, Alabama, United States

Dana V. Rizk, MD

Background

In the randomized Phase III APPLAUSE-IgAN trial (NCT04578834), the complement factor B inhibitor iptacopan (ipta) significantly reduced proteinuria and slowed kidney function decline vs placebo (pbo) over 24 months (m).

Methods

Patients (pts) who completed APPLAUSE-IgAN or the Phase II ipta trial (NCT03373461) could enroll in the ongoing open-label rollover extension program (REP; NCT04557462) and receive ipta 200 mg twice daily + supportive care. The REP evaluates the long-term safety and efficacy of ipta. Safety was analyzed in all pts and efficacy in APPLAUSE-IgAN pts up to data cutoff (DCO; May 26, 2026).

Results

Results are reported from 194 and 174 pts in the ipta and pbo arms of APPLAUSE-IgAN, respectively, who entered the REP. In pts switching from pbo to ipta, annualized total estimated GFR (eGFR) slope was −5.29 mL/min/1.73 m²/year (95% CI −6.09, −4.49) over 24 m on pbo in APPLAUSE-IgAN but improved to −2.11 mL/min/1.73 m²/year (95% CI −3.08, −1.13) over 24 m after switching to ipta in the REP (Figure). In pts switching to ipta, first morning void urine protein–creatinine ratio (UPCR-FMV) remained similar to baseline (BL) on pbo in APPLAUSE-IgAN (geometric mean ratio [GMR] to BL at 24 m: 0.87 [95% CI 0.79, 0.96]) but decreased over 24 m after switching to ipta in the REP (GMR to BL at 48 m: 0.74 [95% CI 0.59, 0.91]). In pts on ipta up to 48 m (APPLAUSE-IgAN + REP), annualized total eGFR slope was −3.49 mL/min/1.73 m²/year (95% CI −4.17, −2.80), and reductions in UPCR-FMV were sustained (GMR to BL at 48 m: 0.61 [95% CI 0.50, 0.75]). After up to 60 m of ipta (N=489), safety outcomes were consistent with those after 24 m in APPLAUSE-IgAN and with other ipta clinical trials. TEAEs led to 4.3% of pts discontinuing ipta; one death due to acute pancreatitis was unrelated to ipta.

Conclusion

Long-term ipta treatment led to improvements vs pbo in eGFR trajectory and proteinuria that were also observed after switching from pbo upon REP entry. The new evidence on long-term exposure of ipta supports the established safety profile of complement inhibition with ipta.

Funding

• Commercial Support – Novartis