Acthar studied in FSGS patients undergoing renal transplantation to measure recurrence rate

This prospective phase 3 study, completed in 2024 with results posted in March 2026, evaluated the use of Acthar in patients with focal segmental glomerulosclerosis (FSGS) undergoing renal transplantation. The study enrolled 15 renal transplant recipients whose primary native kidney disease was FSGS. The target enrollment was 20 patients, but actual enrollment was 15. The target population was patients with primary FSGS. All patients with FSGS were to receive maintenance immunosuppression with belatacept. The primary outcome was the rate of recurrence of FSGS as assessed by renal transplant biopsies and the rate of proteinuria. A secondary endpoint was renal function after transplantation. The study was conducted by the University of Colorado, Denver, starting in February 2019 with primary completion in June 2024. The abstract states that, based on current data, FSGS recurs in 23% of patients after renal transplantation, and therefore it was expected that at least 4 patients would develop recurrent FSGS. The abstract does not report the specific recurrence rate or renal function outcomes from this study, nor does it provide any safety data or p-values, hazard ratios, odds ratios, or confidence intervals. The abstract also does not state the duration of follow-up for enrolled patients or detail any study limitations.

Imagine finally getting a new kidney after living with a serious disease called FSGS, only to worry that the disease might attack your new organ. That's the reality for many transplant patients. This study focused on that exact fear. It followed 15 patients with FSGS who received a kidney transplant. The main goal was to see if giving them a medication called Acthar could change the rate at which FSGS came back. The disease's return is typically tracked in two ways: by checking a biopsy of the new kidney and by measuring protein in the urine, a sign of kidney damage. Based on existing data, the researchers expected about 23% of patients (which would be at least 4 people in this group) to see their FSGS return after the transplant. The study aimed to see if Acthar made a difference in that number. All patients also received standard anti-rejection medication. The study has finished, and the results are now available for review.