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Kidney Week

Abstract: TH-PO1160

Results of a Randomized Placebo-Controlled Double-Blind Adaptive Phase 2 Study (AKITA) Evaluating RMC-035 for the Prevention of AKI in Patients Undergoing Cardiac Surgery

Session Information

  • Late-Breaking Posters
    November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Acute Kidney Injury

  • 102 AKI: Clinical, Outcomes, and Trials

Authors

  • Zarbock, Alexander, Universitatsklinikum Munster, Munster, Nordrhein-Westfalen, Germany
  • Koyner, Jay L., University of Chicago, Chicago, Illinois, United States
  • Boening, Andreas, University Hospital Giessen, Giessen, Germany
  • Engelman, Daniel, Baystate Medical Center, Springfield, Maryland, United States
  • Ronco, Claudio, International Renal Research Institute of Vicenza, Vicenza, Italy
  • Reusch, Michael, Guard Therapeutics, Sweden, Sweden
  • Agervald, Tobias, Guard Therapeutics, Sweden, Sweden
Background

Acute Kidney Injury (AKI) is a common and serious complication following cardiac surgery and is associated with multiple acute and long-term kidney-related adverse outcomes, such as renal replacement therapy, irreversible loss of kidney function, progression of preoperative chronic kidney disease (CKD) and transition to End Stage Kidney Disease (ESKD).
RMC-035 is a recombinant, modified therapeutic protein, mimicking endogenous Alpha-1-Microglobulin, that harbors potent anti-oxidative and heme-binding capacity.

Methods

Global multi-center Phase 2 randomized double-blind adaptive design parallel group study in patients at high AKI risk undergoing open-chest coronary bypass and/or valve surgery with use of cardio-pulmonary bypass. Enrichment for high AKI risk was accomplished by incorporating mandatory AKI risk factors to the eligibility criteria. Patients with eGFR <30 mL/min were excluded from the study.
177 subjects were randomized 1:1 and treated with either RMC-035 or placebo. Study drug was administered up to 2 days after surgery, in total 5 IV infusions. The primary efficacy endpoint was AKI (KDIGO definition) within 72h after surgery. Important secondary endpoints included eGFR change from baseline up to Day 30/90 and MAKE (Major Adverse Kidney Events), a composite defined by death, any post-surgery dialysis or ≥25% eGFR decline from baseline on Day 30/90.

Results

Efficacy results on AKI, eGFR & MAKE and safety will be shared after availability of top-line results which are expected around September 20.

Conclusion

Conclusions will be shared after availability of top-line results, expected around September 20.

Funding

  • Commercial Support – Guard Therapeutics