NCT04080076

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

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NephroNet, Inc. · Academic / Other
• Sex: Male
• Age: 65 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Renal Disease

Interventions

Type	Name	Description
DRUG	Acthar 80 UNT/ML Injectable Solution	ACTHar 80 Units SQ 1042 x Week
DRUG	Oral Tab Tacrolimus	Oral Tab Tacrolimus (1.0 mg PO BID) in combination with ACTHar 80 Units SQ 2 X week

Timeline

• Start date: 2019-01-12
• Primary completion: 2024-09-06
• Completion: 2024-09-06
• First posted: 2019-09-06
• Last updated: 2022-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study