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Corticosteroid

Acthar for FSGS

Phase 3

Waitlist Available

Led By Sixto Giusti, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with FSGS eligible to receive either a live donor or deceased donor kidney transplant

Be older than 18 years old

Must not have

Patients not having FSGS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Approved for 5 Other Conditions

Pivotal Trial

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will test if Acthar can prevent FSGS recurrence in patients undergoing renal transplantation.

Who is the study for?

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.

What is being tested?

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

What are the potential side effects?

While specific side effects for Acthar in this context aren't provided, generally it can cause swelling, weight gain, high blood pressure, mood changes, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have FSGS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of recurrence of FSGS as seen in renal transplant biopsies proteinuria

Rate of recurrence of proteinuria

Secondary study objectives

renal function after transplantation

Side effects data

From 2020 Phase 4 trial • 36 Patients • NCT04169061

Hypertension

Intentional overdose

100%

80%

60%

40%

20%

Study treatment Arm

All Participants

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Corticotropin

FDA approved

0 / 2Eligibility criteria met