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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

Must not have

Patients with active viral production of either hepatitis B or C as evidence by historical polymerase chain reaction test positive for active viral shedding

Patients having received Rituximab or B cell modifying biologic therapy within 6 months of randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I have Type II diabetes without specific kidney damage.

Exclusion Criteria

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

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I have active hepatitis B or C.

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I have not received Rituximab or similar treatments in the last 6 months.

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I have or had lymphoma.

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I do not have MGUS or a history of myeloma.

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

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

Primary study objectives

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 study objectives

Percentage of patients complete or partial response

The change in Estimated Glomerular Filtration Rate

Body Weight Changes

+1 more

Other study objectives

Diabetes Mellitus, Non-Insulin-Dependent

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Pivotal Trial

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

Trial Design

2Treatment groups

Active Control

Group I: 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

Group II: Treatment with Acthar gelActive Control1 Intervention

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

0 / 5Eligibility criteria met