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

• Status: Enrolling by invitation
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NephroNet, Inc.
• Collaborator: Mallinckrodt
• Treatments: Tacrolimus

Criteria

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