Kidney Week

Abstract: TH-PO1213

ANG-3777 Improves Outcomes in Patients with Delayed Graft Function: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial with 12-Month Follow-Up

Session Information

• Late-Breaking Clinical Trials Posters
  November 07, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Transplantation

• No subcategory defined

Authors

• Bromberg, Jonathan, University of Maryland, Baltimore, Maryland, United States

Jonathan Bromberg,

• Weir, Matthew R., University of Maryland School of Medicine, Baltimore, Maryland, United States

Matthew R. Weir,

• Gaber, Ahmed Osama, Houston Methodist Hospital, Houston, Texas, United States

Ahmed Osama Gaber,

• Browne, Barry, Balboa Nephrology Medical Group, San Diego, California, United States

Barry Browne,

• Goldberg, Itzhak D., Angion Biomedica Corp., Uniondale, New York, United States

Itzhak D. Goldberg,

• Yamin, Michael A., Angion Biomedica Corp., Uniondale, New York, United States

Michael A. Yamin,

• Mayne, Tracy J., Angion Biomedica Corp., Uniondale, New York, United States

Tracy J. Mayne,

• Cooper, Matthew, Medstar Georgetown Transplant Institute, Washington, District of Columbia, United States

Matthew Cooper,

Background

Delayed graft function (DGF) is associated with lower graft survival & higher mortality. ANG-3777 is a hepatocyte growth factor mimetic shown in animal models to enhance tissue repair & function in damaged organs.

Methods

Kidney transplant patients producing <50cc urine/H over 8 consecutive hours post-transplant, or with CRR <30% at 24H, were randomized to ANG-3777 (2mg/kg IV QD x 3D; N=19) or Placebo (PBO, N=9). Primary endpoint: median time to ≥1200cc urine/24H.

Results

Study arms were generally balanced, though history of CVD was higher in PBO (ANG-3777=79%, PBO=100%). Kidney/Donor characteristics were similar: Donation after brain death (ANG-3777=68.4%; PBO=77.8%); time from procurement to transplant (ANG-3777= 23.7H+9.2; PBO=23.7H+10.3); DGF incidence (ANG-3777=73.6%; PBO=66.6%). Figure 1: ANG-3777 was more likely to achieve ≥1200cc urine/24H (ANG-3777=79%, median 5 days; PBO=44%, median 14 days). Figure 2: ANG-3777 had higher eGFR at Days 14, 28, 168, 365. Number of dialysis sessions was equivalent (ANG-3777=1.9 Days+1.3; PBO=1.8 Days+1.5), but ANG-3777 had shorter duration of dialysis (4.1+5.5 vs 6.0+8.4 Days) & transplant hospitalization (7.6+2.3 vs 11.4+9.7 Days). PBO had 2 graft failures vs 0 in ANG-3777 (Log Rank χ²=4.6, p=0.03). Treatment Emergent Serious Adverse Events (TESAEs) were similar (ANG-3777=42.1%; PBO=44.4%); TESAEs/subject was higher in PBO (ANG-3777=2.0; PBO=4.3). No TESAEs were drug related.

Conclusion

ANG-3777 showed better short & long-term graft function, and similar safety to PBO.

Funding

• Commercial Support – Angion Biomedica Corp.