Acute Kidney Injury (AKI) is common, expensive to treat, and associated with high mortality [1-4]. Within the field of cardiac surgery, a staggering 30% of patients develop AKI, with significant negative outcomes [1-5]. In the most severe cases, AKI can progress to overt renal failure and dialysis; however, even mild AKI sharply increases the risk of 30-day mortality and long-term progression to chronic kidney disease (CKD) [6].  Although recent research on renal biomarkers has shown promise in diagnosing AKI progression, no tests or models are currently available to effectively identify patients at risk for AKI initiation. If these at-risk patients could be accurately identified prior to surgery, preoperative and perioperative procedures could be modified to minimize the risk of AKI. Such risk minimization is particularly important since there are no pharmacologic therapies available for the effective prevention or treatment of AKI.

Utilizing our proprietary molecular age-based technology (see Technology), HealthSpan Dx has developed AKI-Sapere, a multivariate molecular assay that can prognostically, prior to coronary artery bypass graft (CABG) surgery, successfully stratify patients for risk of AKI initiation. In our preliminary clinical trial in 96 adult patients undergoing CABG, we found that AKI-Sapere identifed 70% of patients at risk for AKI, a huge improvement over 18% predicted by existing models (Cleveland score).  Furthermore, while existing models only predict risk for moderate to severe AKI (stage ≥2), AKI-Sapere can additionally identify patients at risk for mild AKI. These results will be presented at the upcoming AKI & CRRT 2018 conference.

HealthSpan Dx plans to offer AKI-Sapere commercially as a Lab-Developed Test (LDT), for clinicians to use to assess AKI risk prior to CABG surgery. We are also exploring additional applications for AKI-Sapere in other clinical settings. AKI-Sapere can also serve as a patient stratification tool to guide enrollment into AKI clinical trials. At present, testing of therapeutic treatments for AKI is severely hampered by the “low” incidence (~30%) of renal injury in even very high risk populations such as CABG patients.  Use of AKI-Sapere to enroll only those patients at high risk for AKI would dramatically reduce the time and costs of clinical trials, thereby facilitating the development of much-needed AKI therapeutics. Please contact us for more detailed information on how HealthSpan Dx can help with AKI clinical trials.

References

  1. Liangos, O. et al. Epidemiology and outcomes of acute renal failure in hospitalized patients: a national survey. Clin J Am Soc Nephrol 1, 43-51 (2006).
  2. Palevsky, P.M. Epidemiology of acute renal failure: the tip of the iceberg. Clin J Am Soc Nephrol 1, 6-7 (2006).
  3. Uchino, S. et al. Acute renal failure in critically ill patients: a multinational, multicenter study. JAMA 294, 813-818 (2005).
  4. Lameire, N., Van Biesen, W. & Vanholder, R. Acute renal failure. Lancet 365, 417-430 (2005).
  5. Dasta, J.F., Kane-Gill, S.L., Durtschi, A.J., Pathak, D.S. & Kellum, J.A. Costs and outcomes of acute kidney injury (AKI) following cardiac surgery. Nephrol Dial Transplant 23, 1970-1974 (2008).
  6. Chawla, L.S., Amdur, R.L., Amodeo, S., Kimmel, P.L. & Palant, C.E. The severity of acute kidney injury predicts progression to chronic kidney disease. Kidney International 79, 1361-1369 (2011).