NCT02399462

Acthar for Treatment of Post-transplant FSGS

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label safety and feasibility trial using Acthar® in addition to center-specific standard therapy including plasma exchange, for treatment of post transplant recurrent FSGS and post transplant recurrent idiopathic membranous nephropathy. Subjects will receive Acthar® 40 units subcutaneously (SC) twice weekly for two weeks then 80 units SC twice weekly for 24 weeks.

Conditions

• FSGS
• Renal Transplantation
• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Acthar	Agent Dose Route Schedule H.P. Acthar Gel 40 units SC twice weekly\* Weeks 1 and 2 H.P. Acthar Gel 80 units SC twice weekly\* Weeks 3 through 24 H.P. Acthar Gel 80 units SC once weekly\* Weeks 25 through 26 H.P. Acthar Gel 40 units SC once weekly\* Weeks 27 through 28 \*Injections are to be spaced 72-96 hours apart (+/-6 hours).

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-07-31
• Completion: 2021-07-31
• First posted: 2015-03-26
• Last updated: 2021-08-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study