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Kidney Week

Abstract: FR-OR015

One-Year Mortality Follow-Up in Subjects Treated with QPI-1002 at Risk of AKI Following Cardiac Surgery (CS)

Session Information

Category: Acute Kidney Injury

  • 102 AKI: Clinical, Outcomes, and Trials

Authors

  • Lehner, Lukas J., Charité Universitätsmedizin Berlin, Berlin, Germany
  • Schwertschlag, U., Quark Pharmaceuticals, Inc, Fremont, California, United States
  • Odenheimer, D. J., Quark Pharmaceuticals, Inc, Fremont, California, United States
  • Corteville, David, McLaren Northern Michigan, Petoskey, Michigan, United States
  • Szabo, Gabor, University of Heidelberg, Heidelberg, Germany
  • Swaminathan, Madhav, Duke University Medical Center, Durham, North Carolina, United States
  • Lamy, Andre, McMaster University, Hamilton, Ontario, Canada
  • Thielmann, Matthias, West-German Heart and Vascular Center Essen, University Duisburg-Essen, Essen, Germany
  • Green-Ofodu, Amoni D., Quark Pharmaceuticals, Inc, Fremont, California, United States
  • Brown, C. D., New Brunswick Heart Centre, Saint John, New Brunswick, Canada
  • Patel, A., Quark Pharmaceuticals, Inc, Fremont, California, United States
  • Chan, P., Quark Pharmaceuticals, Inc, Fremont, California, United States
  • Cafaro, D. P., Quark Pharmaceuticals, Inc, Fremont, California, United States
  • Mathews, Yuval, Quark Pharmacuticals, Inc, Nes Ziona, Israel
  • Rothenstein, D., Quark Pharmaceuticals, Inc, Nes Ziona, Israel
  • Squiers, Elizabeth C., Quark Pharmaceuticals, Inc, Fremont, California, United States

Group or Team Name

  • QRK209 AKI Study Group
Background

QPI-1002 (QPI), a siRNA targeting p53, is being developed for prevention of Delayed Graft Function (DGF) (NCT#02610296) and for reduction of acute kidney injury (AKI) and its consequences following CS. In a large global Phase 2 double-blind study (N=341: QPI=165, Placebo (PL)=176) (NCT#02610283), QPI reduced the incidence, severity and duration of AKI and reduced the proportion of subjects with major adverse kidney events (MAKE) at Day 90 as previously reported (ASN 2017 Abstract SA-OR124).

Methods

For the primary study, deaths were recorded through Day 90 and causes of death adjudicated by medical dictionary for regulatory activities (MedDRA) coding in a blinded fashion by the medical monitor and safety physician. Longer term mortality was collected at Day 365

Results

Deaths: 22/176 subjects receiving PL and 13/165 subjects receiving QPI died within 365 Days after receiving study drug (p=0.1713). Causes of death were coded to System organ class (SOC): Cardiac Disorders system (3QPI/3 PL), General disorders, (1QPI/5 PL), Infectious disorders (4QPI/4PL), Neoplasm (1PL), Nervous system disorders (2PL), Respiratory disorders (2QPI/2PL), Metabolism (1QPI), Vascular (1QPI) and Not Reported/Unknown(1QPI,5PL). None of the deaths were reported as related to study drug. Eighteen subjects (10 PL and 8 QPI) died within 90 days and 17 subjects (12 PL and 5 QPI) died between D90 and D365.

Conclusion

The results indicate a survival trend through Day 365 in favor of QPI treatment. Additional studies are required to confirm these findings.

Funding

  • Commercial Support