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Kidney Week

Abstract: FR-PO010

Utility of Serum Cystatin C (SCysC) to Assess AKI and Day 90 (D90) Major Kidney Adverse Events (MAKE90) Following Cardiac Surgery (CS) in Subjects Treated with QPI-1002

Session Information

Category: Acute Kidney Injury

  • 102 AKI: Clinical, Outcomes, and Trials


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

Group or Team Name

  • The Quark AKI Study Team

QPI-1002 (QPI), a siRNA targeting p53, is being developed for acute kidney injury (AKI) following CS. KIDGO guidelines recommend assessment of renal function based on SCysC in settings where serum creatinine (SCr) may be unreliable (e.g. decreasing muscle mass).


Initial results from a global Phase 2 double-blind study with QPI for AKI (N=341: QPI=165, Placebo (PL)=176) (NCT#02610283) (presented at ASN 2017: SA-OR124). SCr and SCysC levels were both measured.


QPI significantly reduced (↓) AKI (35.4 % QPI vs 50.6% PL; p=0.0047), ↓AKI severity across all grades (p=0.002), and ↓ AKI duration (p=0.0016) assessed by SCysC similarly to SCr (ASN 2017). In a higher risk subpopulation [proteinuria, low baseline eGFR, and/or insulin dependent diabetes, (N=241)], QPI ↓MAKE (Death, RRT or a ↓in eGFR by 25%) at D90 using eGFRCys (37% QPI vs 51% PL; RRR=29%; p=0.024), but not using eGFRCr. To determine the cause of the divergence of SCr and SCys eGFRs at D90, subjects were grouped by the discordance of SCr and SCys after the method of Grubb using the differences of eGFRs between baseline and D90. Groups were as per Figure 1. The Concordant population (N=114) also had a treatment effect in favor of QPI using eGFRCr for MAKE90 (RRR23%). The largest discordant group, Discordant 1 (N=55), compared to Concordant population, had longer ICU stays (6 vs 4.4 days), more MACE events (10.9 vs. 6.2 %) and had muscle mass loss expressed as ↓sarcopenia index (Kashani et al 2018) with a 28% decrease.


SCr and SCys post CS (D1-D5) were concordant and QPI-1002 significantly reduced the incidence, severity and duration of AKI by either analyte. QPI significantly ↓MAKE 90 in a subpopulation of higher risk subjects when evaluated by SCys. Consistent with other reports, SCr appeared to overestimate eGFR at D90 as compared to SCys in a subset of subjects at risk for decreased SCr production.

Figure 1


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