Phase 3 trial Design of the Hepatocyte Growth Factor Mimetic ANG-3777 in Renal Transplant Recipients With Delayed Graft Function

Flavio Vincenti; Jim Kim; Deborah Gouveia; Gabrielle Pelle; Tracy J Mayne; John F Neylan

doi:10.1016/j.ekir.2020.11.001

Phase 3 trial Design of the Hepatocyte Growth Factor Mimetic ANG-3777 in Renal Transplant Recipients With Delayed Graft Function

Kidney Int Rep. 2020 Nov 13;6(2):296-303. doi: 10.1016/j.ekir.2020.11.001. eCollection 2021 Feb.

Authors

Flavio Vincenti¹, Jim Kim², Deborah Gouveia³, Gabrielle Pelle³, Tracy J Mayne³, John F Neylan³

Affiliations

¹ Department of Medicine and Surgery, University of California at San Francisco, San Francisco, CA.
² Department of Surgery, Keck Medicine of the University of Southern California, Los Angeles, CA.
³ Angion Biomedica, Uniondale, NY.

Abstract

Introduction: One-third of kidney transplantation patients experience acute kidney injury (AKI) resulting in delayed graft function (DGF), associated with increased risk of graft failure and mortality. Preclinical and phase 2 data indicate that treatment with ANG-3777 (formerly BB3), a hepatocyte growth factor (HGF) mimetic, may improve long-term kidney function and reduce health care resource use and cost, but these data require validation in a phase 3 randomized controlled trial.

Methods: The Graft Improvement Following Transplant (GIFT) trial is a multicenter, double-blind randomized controlled trial, designed to determine the efficacy and safety of ANG-3777 in renal transplantation patients showing signs of DGF. Subjects are randomized 1:1 to ANG-3777 (2 mg/kg) administered intravenously once daily for 3 consecutive days starting within 30 hours after transplantation, or to placebo.

Results: The primary endpoint is estimated glomerular filtration rate (eGFR) at 12 months. Secondary endpoints include proportion of subjects with eGFR >30 at days 30, 90, 180, and 360; proportion of subjects whose graft function is slow, delayed, or primary nonfunction; length of hospitalization; and duration of dialysis through day 30. Adverse events are assessed throughout the study.

Conclusion: GIFT will generate data that are important to advancing treatment of DGF in this medically complex population.

Keywords: ANG-3777; acute kidney injury; delayed graft function; eGFR; hepatocyte growth factor; kidney transplantation.