Background: QPI-1002 has been observed to statistically reduce the incidence, severity and duration of AKI in a large Phase 2 study of AKI following cardiac surgery (NCT02610283, J Am Soc Nephrol 28: 2017;1234). The shortage of deceased donor organs has led to the increased use of marginal kidneys including older donors and donors with AKI (defined as a terminal serum creatinine (sCr) ≥ 2.0 mg/dl). Several centers have reported excellent outcomes with AKI donor kidneys in spite of an increased risk of delayed graft function (DGF) (Heilman et al. AJT. 2015;15:2143-51; Farney et al J Am Coll Surg. 2013; 216:645-55). Methods: QPI-1002 has been evaluated in a large Phase 2 study for the prevention of DGF (QRK 006b (NCT# 00802347); [Peddi et al AJT 2014;14 (suppl 3):153 (Abstract #2967); Squiers E et al, AJT 2015;15(suppl 3) (Abstract #448)]. QPI-1002 reduced the severity of DGF in donors age >45. The current analysis looks at the subset of donors from the QRK006B study with donor age was >45 and sCr ≥ 2.0 mg/dl. A negative binomial model was used to determine DGF severity difference between groups. Results: There were a total of 26 kidney transplants performed from AKI donors > age 45 (8 QPI-1002,18 Placebo). Demographics were similar between groups, with donor age 57±9 years and terminal sCr 2.9 ± 1.1 mg/dl (QPI-1002) and 54±5 and 2.1±0.6, respectively (Placebo). The difference between the QPI-1002 and Placebo groups in DGF incidence (dialysis in the first week post-transplant) and DGF severity (defined as the number of dialysis sessions in the first 30 days for subjects with DGF) was statistically significant, with p=0.0077 and p = 0.0006, respectively; and a mean DGF severity of 0.38±0.7 days (QPI-1002) and 4.5 ±4.6 (Placebo). Distribution of dialysis days is graphically displayed below. Conclusions: QPI-1002 may reduce DGF incidence and severity in AKI kidneys from donors >age 45. A Phase 3 study of QPI-1002 in DGF in donors >age 45 (ReGIFT Study, NCT#02610296) is ongoing.

CITATION INFORMATION: Tchervenkov J., Squiers E., Stratta R., Odenheimer D., Rothenstein D., QPI-1002 DGF Study Group QPI-1002, a siRNA Targeting p53: Improvement in Outcomes Following Acute Kidney Injury (AKI): Cardiac Surgery to AKI Donors Am J Transplant. 2017;17 (suppl 3).

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