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

Renal Disease Clinical Trial

Official title:
A Multicenter Comparative and Efficacy Study of ACTHar Gel Alone or in Combination With Tacrolimus in Fibrillary Glomerulopathy

Clinical Trial Summary

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

Clinical Trial 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 in lowering urinary protein to creatinine (UP/Cr) ratios. The addition of tacrolimus patients exhiba partial to ACTH resulted in a further reduction in Fibrillary. Spe #1-will randomize with biopsy proven DNA-JB9 positive Fibrillary glomerulopathy to receive course of ACTHar gel alone at 80 units per week or in combination with oral Tacrolimus at 1 mg BID Hypothesis Treatment with ACTHar Gel with oral Tacrolimus will result in a higher eGFR after 24 months of follow up than patients randomized to ACTHar gel therapy alone. Hy3: Combination therapy of ACTHar Gel and Tacrolimus in patients with DNA-JB9 positive Fibrillary will lead to significant markers of podocyte injury compared ACTHar Gel alone. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04080076
Study type Interventional
Source NephroNet, Inc.
Contact
Status Withdrawn
Phase Phase 4
Start date January 12, 2019
Completion date September 6, 2024
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