Acthar for FSGS

Recruiting in Palo Alto (17 mi)

Overseen bySixto Giusti, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University of Colorado, Denver

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?This study will evaluate the use of Acthar in patients to undergo renal transplantation and will measure the rate of FSGS recurrence.

Eligibility Criteria

This trial is for patients with a kidney condition called Focal Segmental Glomerulosclerosis (FSGS) who are scheduled to receive a kidney transplant from either a living or deceased donor. It's not open to individuals without FSGS.

Inclusion Criteria

I have FSGS and am eligible for a kidney transplant from a live or deceased donor.

Exclusion Criteria

I do not have FSGS.

Participant Groups

The study is testing the effectiveness of Acthar, a medication, in preventing the recurrence of FSGS after patients undergo kidney transplantation.

1Treatment groups

Experimental Treatment

Group I: One armExperimental Treatment1 Intervention

One arm will receive acthar to measure rate of recurrence of FSGS after transplant. There are no other arms. We do have previous data that FSGS recurs in 23% of kidney transplants.

Acthar is already approved in United States for the following indications:

🇺🇸 Approved in United States as Acthar Gel for: