The phase-III trial of Angion’s ANG-3777 did not show a statistically significant difference from placebo on the primary endpoint in the population of dead donor kidney transplant patients who were at risk for developing DGF, according to Vifor Pharma and Angion Biomedica Corp. Furthermore, ANG-3777 showed contradictory results on crucial secondary goals. Based on these findings, there is unlikely adequate evidence to warrant an indication in the DGF group under study.
The statistical analysis plan also included a study of only individuals who finished the trial, rather than utilizing a multiple imputation method to account for missing data and intercurrent events. These findings could point to ANG-3777 biological action. The overall safety profile of ANG-3777 in this trial was consistent with its clinical development program’s broad experience and published literature in this patient population.
In this multi-center, double-blinded, placebo-controlled phase-III trial, 253 patients were randomly assigned to receive either ANG-3777 or a placebo treatment once daily for three days. Eligible individuals were given a deceased donor transplant. They were found to be at risk for delayed graft function if they had decreased urine production (oliguria) for more than 8 hours after the transplant, indicating graft damage. Patients were enrolled in this phase-III registration trial at twenty-five transplant sites across the United States.