Kidney Week

Abstract: FR-PO0831

Baseline Characteristics of ASSIST: Phase 2 Crossover Trial of Atrasentan in Adults with IgAN on SGLT2 Inhibitors

Session Information

• Glomerular Clinical Trials: From Data to Impact
  November 07, 2025 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

• 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

• Mottl, Amy K., Division of Nephrology and Hypertension, University of North Carolina, Chapel Hill, North Carolina, United States

Amy K. Mottl, MD, MPH, FASN

• Mastroianni-Kirsztajn, Gianna, Department of Medicine, Federal University of São Paulo, Sao Paulo, Brazil

Gianna Mastroianni-Kirsztajn, MD, PhD

• Noronha, Irene L., Division of Nephrology, University of São Paulo School of Medicine, São Paulo, Brazil

Irene L. Noronha, MD, PhD

• Lim, Soo Kun, Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia

Soo Kun Lim, MD, FASN

• Gorriz, Jose L., Nephrology Department, Hospital Clínico Universitario de Valencia, University of Valencia, Valencia, Spain

Jose L. Gorriz, MD

• Kotwal, Sradha S., The George Institute for Global Health, Sydney, New South Wales, Australia

Sradha S. Kotwal, MBChB, PhD

• Kim, Sung Gyun, Hallym University Sacred Heart Hospital, Anyang-si, Gyeonggi-do, Korea (the Republic of)

Sung Gyun Kim, MD, PhD

• Barratt, Jonathan, University of Leicester, Leicester, England, United Kingdom

Jonathan Barratt, MBChB, PhD

• Brahmbhatt, Yasmin, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, United States

Yasmin Brahmbhatt

• Housler, Greggory Joseph, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, United States

Greggory Joseph Housler, MSc, MBA

• Jiao, Rong, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, United States

Rong Jiao, PhD

• Heerspink, Hiddo Jan L., Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, Netherlands

Hiddo Jan L. Heerspink, PhD

Background

Atrasentan is a potent and highly selective endothelin A receptor antagonist (ERA), granted accelerated approval by the US FDA for primary IgAN based on an Interim Analysis of the ALIGN (NCT04573478) study. SGLT2i is standard of care in CKD, but minimal evidence exists to support the efficacy and safety of the ERA class in combination with SGLT2i in IgAN. Here we describe baseline (BL) characteristics of participants (pts) enrolled in ASSIST (NCT05834738), a randomized, double-blind, placebo-controlled, crossover study of atrasentan in adults with IgAN using RASi and SGLT2i.

Methods

Pts with biopsy-proven IgAN, eGFR ≥30 mL/min/1.73 m², on stable RASi and SGLT2i were enrolled. Pts not on stable SGLT2i had to complete an 8-week (wk) run-in period of SGLT2i stabilization. All pts needed a 24-hr total urine protein of >0.5 g/d prior to randomization. Pts were randomized 1:1 to either sequence AB or sequence BA in which they received either 0.75 mg atrasentan once daily in one period and matching placebo in the other period as per the randomization schema (Figure). The primary and secondary endpoints are the change in proteinuria (24-hr UPCR) from BL to wk 12 and wk 24 (in Treatment period 2), respectively.

Results

54 pts (47 SGLT2i stable, 7 run-in) were randomized across 6 countries; mean age 47.7 years, 57.4% male, 64.8% white and median UPCR 1.0 g/g. BL data are shown in Table.

Conclusion

ASSIST includes pts who remain at an increased risk of kidney failure despite maximally tolerated RASi and SGLT2i with urine protein >0.5g/d at BL. The study will provide evidence for the efficacy and safety of atrasentan in combination with SGLT2i in IgAN pts with a broad range of proteinuria levels.

Funding

• Commercial Support – The study is sponsored by Novartis Pharmaceuticals

Digital Object Identifier (DOI)

• doi: 10.1681/ASN.20251m9dyn78