The hepatocyte growth factor mimetic, ANG-3777, in kidney transplant recipients with delayed graft function: Results from a randomized phase 3 trial.
Vincenti, F., et al.American Journal of Transplantation 2024; 24(9): 1644-1651.
Aims
The aim of this study was to examine the role of hepatocyte growth factor mimetic, ANG-3777, in deceased donor renal transplant patients with delayed grafts fucntion.
Interventions
Participants were randomised to receive ANG-3777 or placebo.
Participants
253 first kidney transplant deceased donor recipients (adults ≥18 years old, body mass index of <40 kg/m2)
Outcomes
Originally, the primary outcome was duration of dialysis through day 30, which was later revised to estimated glomerular filtration rate (eGFR) at day 360. The main secondary endpoint was severity of DGF.
Follow-up
360 days posttransplant
CET Conclusions
This randomised, double-blinded, controlled trial investigated the use of a hepatic growth factor mimetic, ANG-3777 in renal transplantation. The study was very close to reaching adequate power, but slightly under in the end. There was no significant difference in the rate of DGF between the placebo and study arms identified. The rate of DGF in this study seems to be very high (over 60%), despite approximately 80% of donation being after brain death and cold ischaemic time being acceptable. The anastomosis time reported in the table seems incredibly high (230 minutes mean), to the extent that it must be incorrectly printed, or using an unfamiliar definition. Patients were followed up to day 360 for eGFR, and no difference was seen. There were no safety concerns with the administration of ANG-3777.
Data analysis
Modified intention-to-treat analysis
Trial registration
ClinicalTrials.gov - NCT02474667