← Back to Search

Corticosteroid

Acthar Gel for Fibrillary Glomerulonephritis (FACT Trial)

Phase 4

Waitlist Available

Led By James Tumlin, MD

Research Sponsored by NephroNet, Inc.

Eligibility Criteria Checklist

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

Must have

Patients with Type II non-insulin dependent diabetes will be eligible provided the renal biopsy does not show nodular Kimmelstiel Wilson lesions

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

FACT Trial Summary

This trial is studying the safety and efficacy of Acthar gel to reduce urinary proteinuria in patients with fibrillary glomerulopathy.

Who is the study for?

This trial is for adults over 18 with Fibrillary glomerulonephritis diagnosed within the last 3 years, stable on RAAS inhibitors, and have a certain level of protein in their urine. It's not for those with a history of myeloma, HIV, severe kidney damage, insulin-dependent diabetes or recent use of certain immune therapies.Check my eligibility

What is being tested?

The study tests Acthar Gel alone or combined with Tacrolimus to reduce proteinuria in patients with DNAJB9 Positive Fibrillary glomerulopathy. Participants will be randomly assigned to receive one treatment or the other.See study design

What are the potential side effects?

Acthar Gel can cause swelling, increased blood pressure and sugar levels, mood changes, and risk of infections. Tacrolimus may lead to kidney problems, tremors, high potassium levels, and could increase infection risk.

FACT Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have Type II diabetes without specific kidney damage.

FACT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Therapeutic procedure

The change in UP/CR ratio with treatment of Acthar gel 80 units subcutaneous 2 times a week in combination with oral Tacrolimus

Secondary outcome measures

Percentage of patients complete or partial response

The change in Estimated Glomerular Filtration Rate

Body Weight Changes

+1 more

Other outcome measures

Diabetes Mellitus, Non-Insulin-Dependent

FACT Trial Design

2Treatment groups

Active Control

Group I: Treatment with Acthar gelActive Control1 Intervention

Group 1 - (17 patients) Acthar gel 80 units 2 times a week alone for 12 months of therapy.

Group II: Treatment with combination Acthar gel and Tacrolimus therapyActive Control1 Intervention

Group 2 - (17 patients) Acthar get 80 units 2 times a week plus oral Tacrolimus 1.0 mg two times a day titrated to trough Tacrolimus levels between 4-6 ng/ml

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

NephroNet, Inc.Lead Sponsor

2 Previous Clinical Trials

88 Total Patients Enrolled

MallinckrodtIndustry Sponsor

201 Previous Clinical Trials

16,194 Total Patients Enrolled

Jeremy Whitson, BSStudy DirectorNephroNet, Inc.

1 Previous Clinical Trials

88 Total Patients Enrolled

Media Library

Acthar Gel (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05546047 — Phase 4

Fibrillary Glomerulonephritis Research Study Groups: Treatment with Acthar gel, Treatment with combination Acthar gel and Tacrolimus therapy

Fibrillary Glomerulonephritis Clinical Trial 2023: Acthar Gel Highlights & Side Effects. Trial Name: NCT05546047 — Phase 4

Acthar Gel (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05546047 — Phase 4

Frequently Asked Questions

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

To what degree is the usage of Acthar gel deemed hazardous?

"The safety of Treatment with Acthar gel has been rated a 3, as this is an FDA-approved Phase 4 trial."

Answered by AI

What aims are being pursued in this research endeavor?

"This monitored clinical trial is set to run for 12 months and its primary objectives are to assess the UP/CR ratio in patients receiving Acthar gel 80 units subcutaneously twice a week combined with oral Tacrolimus. Secondary outcomes include relative change of protein/creatinine level at 24 months post-treatment, percentage of participants achieving complete or partial response within 12 months of therapy, and comparison between baseline urinary biomarkers such as VEGF 121, 165 189, 206; MCP-1; Synaptopodin; TGF-beta; Podocalyxin; Nephrin after treatment with either Acthar gel alone"

Answered by AI

What is the scope of sites where this examination is taking place?

"This trial is running in 5 distinct sites, located within the cities of Aurora, Bethlehem and Lawrenceville among others. In order to make participation more comfortable for everyone involved it is strongly recommended that patients join their closest clinic."

Answered by AI

Is recruitment still in progress for this clinical experiment?

"According to clinicaltrials.gov, the posting of this trial was launched on March 14th 2019 and its last update took place on October 27th 2022; however, it is not currently recruiting any new patients for participation. Nevertheless, 29 other studies are still open for recruitment at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Acthar Gel Alone or With Tacrolimus to Reduce Proteinuria in Fibrillary Glomerulopathy Patients

2019. "A Study of Acthar Gel Alone or With Tacrolimus to Reduce Proteinuria in Fibrillary Glomerulopathy Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05546047.