Treatment with Acthar gel for Fibrillary Glomerulonephritis

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Columbia University Research Dept of Nephrology, New York, NY
Fibrillary Glomerulonephritis+2 More
Acthar Gel 80 UNT/ML Injectable Solution - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

A Multicenter, Comparative Safety and Efficacy Study of Acthar gel alone or in combination with oral Tacrolimus to reduce urinary proteinuria in patients with idiopathic DNAJB9 Positive Fibrillary glomerulopathy.

Eligible Conditions

  • Fibrillary Glomerulonephritis

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Fibrillary Glomerulonephritis

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: 24 months

12 months
Percentage of patients complete or partial response
The change in UP/CR ratio with treatment of Acthar gel 80 units subcutaneous 2 times a week alone
The change in UP/CR ratio with treatment of Acthar gel 80 units subcutaneous 2 times a week in combination with oral Tacrolimus
To compare the change in urinary biomarkers of Urinary VEGF 121, 165 189, and206, Urinary MCP-1, Urinary Synaptopodin, Urinary TGF-beta, Urinary Podocalyxin, and Urinary Nephrin
24 months
The change in Estimated Glomerular Filtration Rate
The relative change in protein/creatinine ratio at 24 months
To determine if patients with concurrent Type II diabetes mellitus resulted in hyperglycemia, increased proteinuria, loss of renal function or led to immunosuppressive therapies

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Fibrillary Glomerulonephritis

Trial Design

2 Treatment Groups

Treatment with Acthar gel
1 of 2
Treatment with combination Acthar gel and Tacrolimus therapy
1 of 2
Active Control

34 Total Participants · 2 Treatment Groups

Primary Treatment: Treatment with Acthar gel · No Placebo Group · Phase 4

Treatment with Acthar gel
Drug
ActiveComparator Group · 1 Intervention: Acthar Gel 80 UNT/ML Injectable Solution · Intervention Types: Drug
Treatment with combination Acthar gel and Tacrolimus therapy
Drug
ActiveComparator Group · 1 Intervention: Acthar Gel 80 UNT/ML Injectable Solution · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
Closest Location: Columbia University Research Dept of Nephrology · New York, NY
Photo of New York  1Photo of New York  2Photo of New York  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Fibrillary Glomerulonephritis
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are female or male and are 18 years of age or older.
You have a kidney biopsy proven Fibrillary glomerulonephritis within 3 years of study randomization.
Protein/creatinine ratio > 2000 mg/gm or total 24-hour protein >/= 2000mg.
Patients with Monoclonal Gammopathy without history of myeloma will be eligible.
Patients with monoclonal staining for fibrillary fibers will be excluded.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.