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

NephroNet, Inc.

Status and phase: Active, not recruiting; Phase 4

Conditions: Fibrillary Glomerulonephritis

Treatments: Drug: Acthar Gel 80 UNT/ML Injectable Solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05546047

NN-002

Details and patient eligibility

About

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.

Full description

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. This study will be a multi-center, prospective, randomized, open-labeled intervention trial of 34 patients randomized to 52 weeks of ACTHar gel alone or Acthar gel plus oral Tacrolimus.

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male/Female age > 18
• Biopsy proven Fibrillary glomerulonephritis within 3 years of study randomization
• Stable Maximum Renin-Angiotensin-Aldosterone System inhibition times 4 weeks prior to randomization Note: Maximum RAAS inhibition will be left to the discretion of the site Principal Investigator
• Estimated Glomerular Filtration Rate > 25 mls/min calculate by the Chronic Kidney Disease-EPI formula
• Protein/creatinine ratio > 2000 mg/gm 5) Note: If protein/creatinine less than 2000 mg/gm, a formal 24- hour urine collection for total protein can be performed. The total 24-hour protein will need to >/= 2000mg.
• Blood pressure targeted to < 140/90 at the time of randomization
• Patients with Monoclonal Gammopathy without history of myeloma will be eligible.
• Patients with monoclonal staining for fibrillary fibers will be excluded
• Patients with Type II non-insulin dependent diabetes will be eligible provided the renal biopsy does not show nodular Kimmelstiel Wilson lesions

Exclusion criteria

• Patients with MGUS and history of myeloma will not be eligible
• Patients with active viral production of either hepatitis B or C as evidence by historical polymerase chain reaction test positive for active viral shedding
• HIV seropositivity
• Renal biopsy data with > 50% Interstitial Fibrosis
• Patient with active or a known history lymphoma
• Patients with insulin dependent diabetes mellitus will be excluded Note: patients with Type II diabetes mellitus that are well controlled without the need for insulin will be eligible for the study.
• Patients with Type II non-insulin dependent diabetes will be eligible provided the renal biopsy does not show nodular Kimmelstiel Wilson lesions.
• Patients receiving steroids, mycophenolate mofetil, cyclophosphamide, Azathioprine or other immunosuppressive agent with 4 weeks of study randomization Note: Washout of these medications will be allowed at the screening visit
• Patients having received Rituximab or B cell modifying biologic therapy within 6 months of randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Treatment with Acthar gel

Active Comparator group

Description:

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

Treatment:

Drug: Acthar Gel 80 UNT/ML Injectable Solution

Treatment with combination Acthar gel and Tacrolimus therapy

Active Comparator group

Description:

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

Treatment:

Drug: Acthar Gel 80 UNT/ML Injectable Solution