Kidney Week

Abstract: TH-OR084

POINTER: A Phase 2b, Randomized, Placebo-Controlled, Double-Blind Dose-Finding Clinical Study of RMC-035 in Participants at High Risk for Kidney Injury Following Cardiac Surgery

Session Information

• Late-Breaking Research Orals - 1
  November 06, 2025 | Location: Grand Ballroom C, Convention Center
  Abstract Time: 04:30 PM - 04:42 PM

Category: Acute Kidney Injury

• 102 AKI: Clinical, Outcomes, and Trials

Authors

• Koyner, Jay L., The University of Chicago, Chicago, Illinois, United States

Jay L. Koyner, MD, FASN

• Zarbock, Alexander, Universitatsklinikum Munster Klinik fur Anasthesiologie Operative Intensivmedizin und Schmerztherapie, Muenster, NRW, Germany

Alexander Zarbock, MD

• Myjavec, Andrej, Fakultni Nemocnice Hradec Kralove, Hradec Kralove, Czechia

Andrej Myjavec, MD

• Muñoz Carvajal, Ignacio, Hospital Universitario Reina Sofia, Córdoba, AL, Spain

Ignacio Muñoz Carvajal, PhD, MD

• Burkert, Jan, Univerzita Karlova, Prague, Czechia

Jan Burkert, PhD, MD

• Boehm, Johannes, Technische Universitat Munchen School of Medicine and Health, Munich, BY, Germany

Johannes Boehm, PhD, MD

• Roselló-Díez, Elena, Hospital de la Santa Creu i Sant Pau, Barcelona, CT, Spain

Elena Roselló-Díez, DrPH

• Matschke, Klaus E, Herzzentrum Dresden GmbH Universitatsklinik an der Technischen Universitat Dresden, Dresden, SN, Germany

Klaus E Matschke, PhD, MD

• de Varennes, Benoit, McGill University Faculty of Medicine and Health Sciences, Montreal, Quebec, Canada

Benoit de Varennes, DrMed, MMSc

• Boening, Andreas, Justus-Liebig-Universitat Giessen, Giessen, HE, Germany

Andreas Boening, MD, PhD

• Candela-Toha, Angel M, Hospital Universitario Ramon y Cajal, Madrid, Community of Madrid, Spain

Angel M Candela-Toha, MD

• Agervald, Tobias, Guard Therapeutics, Stockholm, Sweden

Tobias Agervald, MD, PhD

• Reusch, Michael, Guard Therapeutics, Stockholm, Sweden

Michael Reusch, DrMed

Group or Team Name

• POINTER Study Group.

Background

Cardiac surgery with cardiopulmonary bypass (CPB) carries risks such as AKI and CKD progression. In the Phase 2a AKITA study, RMC-035, an alpha-1-microglobulin analogue, showed potential for kidney protection. The POINTER study assessed its dose effect on preserving postoperative renal function.

Methods

Patients with eGFR ≥30 mL/min/1.73m² undergoing non-emergent cardiac surgery with CPB were randomized (stratified by eGFR <60 vs ≥60 mL/min) to placebo, 30 mg, or 60 mg RMC-035 (3:2:2) and followed for 90 days. The primary endpoint was absolute eGFR change from baseline; the key secondary endpoint was major adverse kidney events (MAKE) at Day 90. Additional endpoints included MAKE at Day 60 and AKI at Day 4. Safety was evaluated via adverse events and labs.

Results

170 subjects were randomized and treated with study drug at 19 cardiac surgery centers in Canada, Czech Republic, Germany, and Spain. Patients were predominantly white (n=165), and male (n=123) with a mean age of 70.9 years. Mean baseline eGFR was 74.2 mL/min/1.73m² with a majority of patients (n=120) in the ≥60 mL/min stratum. Key efficacy and safety results are expected by the end of October 2025.

Conclusion

The results will provide critical evidence of RMC-035’s kidney-protective potential in cardiac surgery patients at high risk of renal injury. As a first-in-class candidate, it may offer a novel treatment option in an area of high unmet need. Findings will inform optimal dosing and benefit-risk assessment for a future pivotal Phase 3 trial.

POINTER - Key Demographics and Baseline Characteristics [N=170]

Funding

• Commercial Support – Guard Therapeutics International AB

Digital Object Identifier (DOI)

• doi: 10.1681/ASN.20258q224sf0