Abstract: SA-PO0652
Atrasentan in Patients (Pts) with IgAN from East (E) Asia: Phase 3 ALIGN Final Data
Session Information
- Glomerular Diseases: Clinical, Outcomes, and Therapeutics Research - Other
October 24, 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
- Zhang, Hong, Peking University First Hospital Department of Nephrology Renal Division, Beijing, China
- Lee, Sangho, Kyung Hee University Hospital at Gangdong, Gangdong-gu, Seoul, Korea (the Republic of)
- Hou, Fan Fan, Nanfang Hospital of Southern Medical University, Guangzhou, China
- Wu, Vincent, National Taiwan University Hospital, Taipei City, Taiwan
- Tang, Sydney, The University of Hong Kong, Hong Kong, Hong Kong
- Heerspink, Hiddo Jan L., University of Groningen, University Medical Center Groningen, Groningen, Netherlands
- Barratt, Jonathan, The Mayer IgA Nephropathy Laboratories, University of Leicester, Leicester, United Kingdom
- Jardine, Meg, NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia
- Kohan, Donald E., University of Utah Heath, Salt Lake City, Utah, United States
- Lafayette, Richard A., Stanford University, Stanford, California, United States
- Levin, Adeera, Division of Nephrology, The University of British Columbia, Vancouver, British Columbia, Canada
- Mallik, Suparna, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, United States
- Li, Yuhan, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, United States
- Lodha, Amit, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, United States
- Kollins, Dmitrij, Novartis Pharma AG, Basel, BS, Switzerland
- Liew, Adrian, Mount Elizabeth Novena Hospital, Singapore, Singapore
Background
In ALIGN (NCT04573478), atrasentan, a selective ETA receptor antagonist, reduced proteinuria after 36 weeks (W), preserved kidney function after 2.5 years and was well tolerated in adults with IgAN. We assessed efficacy and safety in pts from E Asia, a population with high IgAN prevalence and risk of progression to kidney failure.
Methods
ALIGN is a double-blind, Phase 3 trial in adults with IgAN and 24-hour total urine protein ≥1 g/day on optimized supportive care. Pts were randomized to atrasentan 0.75 mg or placebo (pbo) daily for 132W with 4W follow-up. The key secondary endpoint was change in eGFR from baseline to W136 in the main study cohort (no background SGLT2i use). Exploratory analyses were done in pts from E Asia (China, Japan, Korea, Other; atrasentan n=68; pbo n=70) in this cohort.
Results
Baseline characteristics and demographics were balanced between study arms. Median baseline UPCR was 1.43 g/g (Q1, Q3: 1.09, 1.95). Mean baseline eGFR was 61 ml/min/1.73 m2 (SD 24.67). At W136, the difference in eGFR change from baseline for atrasentan vs pbo was 1.62 ml/min/1.73m2 (95% CI: -2.35, 5.60; Table). At W132 the difference in eGFR change from baseline was 1.80 ml/min/1.73m2 (95% CI: -1.69, 5.29). Atrasentan vs pbo reduced eGFR rate of decline (annualized total slope) by 1.07 ml/min/1.73m2/year (95% CI: -0.29, 2.44). Proportions of pts reaching partial proteinuria remission and proteinuria <1 g/day at W36 were greater for atrasentan vs pbo (Table). Atrasentan was well tolerated with no new safety signals. Fluid retention adverse events occurred in 7 (10.3%) pts on atrasentan vs 4 (5.7%) on placebo; none led to discontinuation.
Conclusion
These results in pts from E Asia are consistent with the overall ALIGN population showing that 2.5 years of atrasentan treatment preserves kidney function and is well tolerated with a consistent safety profile.
Funding
- Commercial Support – Novartis