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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Rate of recurrence of proteinuria

Secondary outcome measures

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

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,143,563 Total Patients Enrolled

Sixto Giusti, MDPrincipal InvestigatorUniversity of Colorado, Denver

Monica B Grafals, MD, MPHPrincipal InvestigatorUniversity of Colorado, Denver

Media Library

Acthar (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT02683889 — Phase 3

Focal Segmental Glomerulosclerosis Research Study Groups: One arm

Focal Segmental Glomerulosclerosis Clinical Trial 2023: Acthar Highlights & Side Effects. Trial Name: NCT02683889 — Phase 3

Acthar (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02683889 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the most severe outcome that could result from using Acthar?

"While there is some data supporting the efficacy of Acthar, it has also undergone multiple rounds of testing to confirm its safety. As such, our team at Power rates its safety as a 3 on a scale from 1 to 3."

Answered by AI

How is Acthar Gel most commonly employed?

"Acthar has been shown to be an effective medical intervention for acute coryza, rheumatoid arthritis, juvenile, and optic neuritis."

Answered by AI

Are there any open positions for individuals in this particular clinical trial?

"That is correct. As of today, the clinical trial indicated on clinicaltrials.gov is still recruiting patients which began on 2/1/2019. The study requires 20 more participants and is being hosted at 1 site."

Answered by AI

Are minors part of this research project?

"The age limit for participants in this study is 80 years old, with a minimum age of 18."

Answered by AI

Does Acthar have a history of being studied in other clinical trials?

"The current number of trials studying Acthar is 10, 3 of which are large-scale Phase 3 studies. The majority of these research projects are taking place in Minneapolis, although other locations across the United States (105 in total) are also conducting their own investigations."

Answered by AI

How can I become a subject in this experiment?

"20 fsgs patients aged between 18-80 years old, who have either received a live donor or deceased donor kidney transplant, are being recruited for this clinical trial."

Answered by AI

How many people are currently signed up to take part in this clinical trial?

"That is correct. The clinicaltrials.gov website has information indicating that this trial is looking for participants. 20 individuals are needed for the study, which is being conducted at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Use of Acthar in Patients With FSGS That Will be Undergoing Renal Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02683889.

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