Comparative and Efficacy Study of ACTHar Gel Alone or in Combination With Tacrolimus in Fibrillary Glomerulopathy

• Status: Recruiting
• Trial end date: 2022-03-14
• Target enrollment: 0
• Participant gender: All

Summary

Treatment with combination ACTHar gel and Tacrolimus therapy or ACTHar gel therapy alone in lowering urinary protein to creatinine (UP/Cr) ratios

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

Details

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

Criteria

Histologic Inclusion Criteria:

All patients with a diagnosis of The Fibrillary GN wbe classified according to the Nasr nomenclature:

1. Renal biopsy demonstrating JB9 Positive staining within 3 years of study randomization

2. Mesangial expansion with/without glomerular sclerosis diffuse sclerosis

4) Crescents orocapillary proliferation Note: Patients with > 50% interstitial fibrosis will not be eligible for study Note: Patients with monoclonal will not be eligible for study participation

Inclusion Criteria:

1. Male/Female ag

2. Biopsy proven Fibrillary GN wityears of study randomization

3. Stable Maximum RAAS inhibition X 4 weeks prior to randomization Note: Maximum inhibition will be the discretion of the site PI

4. eGFR > 25 mls/min calculate b formu

5. UP/Cr ratio > 2000 mg/gm 5 Note: IF UP/Cr less than 2000 mg/gm, a formal urine collection for total protein can be performed. The total 24-hour will need to >/= 2000mg.

6. Blood pressure targeted to < 140at the time of randomization

7. Patients with MGUS without history of myeloma WILL be eligible.

8. Patients with monoclonal staining for fibrillary fibers will be excluded

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

Exclusion

1. Patients with MGUS and history of myeloma WILL be eligible

2. Patients with active viral production of either B or C as evidence by historical PCR test positive for active vir shedding

3. HIV seropositivity

4. Renal biopsy data with > 5Interstitial Fibrosis

5. Patient with active or a known history

6. Patients with insulin Dependent diabetes mellitus will be excluded Note: patients with T are well controlled WITHOUT the need for insulin WILL be eligible for the study.

7. Patients with Type II non-insulin dependent diabetes WILL be eligible provided the renal biopsy does not s nodular Kimmelstiel Wilson lesions.

8. Patients receiving steroids, MMF, cyc, Azathioprine or other immunosuppressive agent with of study random Note: Wash medications will be allowed at the screening visit

9. Patients having received Rituximab or B cell modifying biologic therapy within 6 months of randomiza