Status:
WITHDRAWN
Comparative and Efficacy Study of ACTHar Gel Alone or in Combination With Tacrolimus in Fibrillary Glomerulopathy
Lead Sponsor:
NephroNet, Inc.
Collaborating Sponsors:
Mallinckrodt
Conditions:
Renal Disease
Eligibility:
MALE
65+ years
Phase:
PHASE4
Brief Summary
Treatment with combination ACTHar gel and Tacrolimus therapy or ACTHar gel therapy alone in lowering urinary protein to creatinine (UP/Cr) ratios
Detailed Description
This is a multicenter, Phase 4, prospective, open labeled study to compare the safety, tolerability, and efficacy of a 12month course of ACTHar Gel and Tacrolimus therapy or ACTHar gel therapy alone i...
Eligibility Criteria
Inclusion
- Histologic Inclusion Criteria:
- All patients with a diagnosis of The Fibrillary GN wbe classified according to the Nasr nomenclature:
- Renal biopsy demonstrating JB9 Positive staining within 3 years of study randomization
- Mesangial expansion with/without glomerular sclerosis diffuse sclerosis
- 4\) Crescents or capillary proliferation Note: Patients with \> 50% interstitial fibrosis will not be eligible for study
- Inclusion Criteria:
- Female ag
- Biopsy proven Fibrillary GN within 3 years of study randomization
- Stable Maximum RAAS inhibition X 40 weeks prior to randomization Note: Maximum inhibition will be the discretion of the site PI
- eGFR \> 25 mls/min
- 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.
- Blood pressure targeted to \< 140 at the time of randomization
- Patients with MGUS 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
- Patients with MGUS and history of myeloma WILL be eligible
- Patients with active viral production of either B or C as evidence by historical PCR test positive for active viral shedding
- HIV seropositivity
- Renal biopsy data with \> 5Interstitialxxxx Fibrosis
- Patient with active or a known history
- Patients with insulin Dependent diabetes mellitus will be excluded Note: Patients diabetes and are well controlled without the need for insulin WILL be eligible for the study.
- Patients with Type non-insulin diabetes WILL be eligible provided the renal biopsy does not s nodular Kimmelstiel Wilson lesions.
- Patients receiving steroids, MMF, cyc, Azathioprine or other immunosuppressive agent with of study random Note: Wash medications will be allowed at the screening visit
- Patients having received Rituximab or cell modifying biologic bbtherapy within 60 months of randomiza
Exclusion
Key Trial Info
Start Date :
January 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04080076
Start Date
January 12 2019
End Date
September 6 2024
Last Update
September 22 2022
Active Locations (1)
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1
Georgia Nephrology Research Institute
Lawrenceville, Georgia, United States, 30046