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.
Can a medication help prevent kidney disease from returning after transplant?
Plain Language Summary
What this means for you:
A study tested if Acthar could prevent FSGS from returning after a kidney transplant. What this means for you:
A study tested if Acthar could prevent FSGS from returning after a kidney transplant. View Original Abstract ↓
Status: COMPLETED | Phase: PHASE3
Condition(s): FSGS
Intervention(s): Acthar (DRUG)
This study will evaluate the use of Acthar in patients to undergo renal transplantation and will measure the rate of FSGS recurrence.
Detailed: This is a prospective study enrolling renal transplant recipients with the primary native kidney disease of FSGS.
Primary endpoint is rate of recurrence of FSGS as seen in renal transplant biopsies and in rate of proteinuria. Secondary endpoint is renal function after transplantation The target subject number is 20 patients and the target population is primary FSGS patients. By the current data, FSGS should recur in 23% of patients. Therefore, it would be expected that at least 4 patients will develop recurrent FSGS after renal transplantation.
Screening will be performed by the Principal Investigator during the kidney transplant evaluation clinics and during the wait list kidney transplant evaluation clinic. All patients with FSGS will have maintenance immunosuppression with belatacept
Primary Outcome(s): Rate of Recurrence of FSGS as Seen in Renal Transplant Biopsies Proteinuria; Rate of Recurrence of Proteinuria
Enrollment: 15 (ACTUAL)
Lead Sponsor: University of Colorado, Denver
Start: 2019-02-01 | Primary Completion: 2024-06-06
Results posted: 2026-03-23