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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
This study will evaluate the use of Acthar in patients to undergo renal transplantation and will measure the rate of FSGS recurrence.
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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Medstar Georgetown Transplant Institute
Washington D.C., District of Columbia, United States
Start Date
February 1, 2019
Primary Completion Date
June 1, 2024
Completion Date
June 1, 2024
Last Updated
April 8, 2024
20
ESTIMATED participants
Acthar
DRUG
Lead Sponsor
University of Colorado, Denver
NCT07267026
NCT05505500
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05508009