NCT02683889

Use of Acthar in Patients With FSGS That Will be Undergoing Renal Transplantation

The Use of Acthar (ACTH) in Patients With Focal Segmental Glomerulosclerosis (FSGS) Who Have Developed Chronic Kidney Disease Stage V (CKD) or End Stage Renal Disease (ESRD) and Are Undergoing a Renal Transplant

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the use of Acthar in patients to undergo renal transplantation and will measure the rate of FSGS recurrence.

Detailed description

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 (if EBV positive), prograf, cellcept and prednisone. If after one year the patient has been stable and there has not been rejection, will stop the prograf and continue solely with belatacept, cellcept and prednisone. Dosage and Administration of Acthar The dose of acthar to be given to every enrolled patient will be 80 units twice a week for 6 months.

Conditions

• FSGS

Interventions

Type	Name	Description
DRUG	Acthar	patients will receive acthar 80 units twice a week for 6 months and will measure recurrence of FSGS

Timeline

• Start date: 2019-02-01
• Primary completion: 2024-06-06
• Completion: 2024-06-10
• First posted: 2016-02-17
• Last updated: 2026-03-23
• Results posted: 2026-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study