Acthar studied in FSGS patients undergoing renal transplantation to measure recurrence rateCan a medication help prevent kidney disease from returning after transplant?

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