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

  • STATUS
    Recruiting
  • End date
    Dec 27, 2023
  • participants needed
    20
  • sponsor
    University of Colorado, Denver
Updated on 27 January 2021
kidney transplant
acthar

Summary

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

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.

Details
Condition Focal glomerulosclerosis, Focal Segmental Glomerulosclerosis
Treatment ACTHAR
Clinical Study IdentifierNCT02683889
SponsorUniversity of Colorado, Denver
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

FSGS
To receive either a live donor or deceased donor kidney transplant

Exclusion Criteria

Not having FSGS
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