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Kidney Week

Abstract: PO2418

Design of the Graft Improvement Following Transplant (GIFT) Trial, a Phase 3 Study of ANG-3777 in Kidney Transplantation Patients with Delayed Graft Function

Session Information

Category: Transplantation

  • 1902 Transplantation: Clinical

Authors

  • Vincenti, Flavio, University of California San Francisco, San Francisco, California, United States
  • Mayne, Tracy J., Angion Biomedica, San Francisco, California, United States
  • Gouveia, Deb, Angion Biomedica, San Francisco, California, United States
  • Neylan, John F., Angion Biomedica, San Francisco, California, United States
Background

Patients after kidney transplantation can experience acute kidney injury (AKI) resulting in delayed graft function (DGF). The Food and Drug Administration has prioritized the development of new treatments for DGF. A Phase 2 trial demonstrated that treatment with ANG-3777, a hepatocyte growth factor (HGF) mimetic, improved renal function up to 12-months in patients with signs of DGF.

Methods

Objective: To describe the GIFT trial (Study 001-15), designed to evaluate the efficacy and safety of ANG-3777 in renal transplantation patients with signs of DGF

Results

GIFT is a Phase 3, multicenter, prospective, randomized, placebo-controlled, study enrolling patients who have undergone a kidney transplantation with a deceased donor kidney who exhibit signs of DGF (producing a mean of <50cc urine per hour over 8 hours in the first 24-hours post-transplantation). Patients are randomized 1:1 to ANG-3777 (2 mg/kg) or placebo administered intravenously once daily for 3 consecutive days starting within 30 hours after transplantation. The primary endpoint is estimated glomerular filtration rate (eGFR) at 12 months. Secondary endpoints include proportion of subjects with eGFR > 30 mL/min/1.73m2 at days 30, 90, 180 and 360; proportion of subjects whose graft function is slow, delayed or primary non-function; length of hospitalization; duration of dialysis through day 30. A study schematic is shown in Figure 1. Adverse events are being assessed throughout the study.

Conclusion

No pharmacologic intervention has been demonstrated in a rigorous trial to be effective preventing or improving the outcome of DGF. The GIFT study will generate data that are critical to advancing the treatment of DGF.