Acthar for Treatment of Post-transplant FSGS

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 31, 2021

Interventions

  • 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).

Arms, Groups and Cohorts

  • Experimental: Study Drug Arm
    • Acthar SC injections

Clinical Trial Outcome Measures

Primary Measures

  • number of patients with proteinuria
    • Time Frame: 24 and 52 weeks
    • partial and complete remission of proteinuria

Secondary Measures

  • Graft loss
    • Time Frame: during study period
    • graft loss defined by return to dialysis, re-transplant or death during study period
  • eGFR change
    • Time Frame: weeks 4,8,12,16,20 and 24
    • estimated Glomerular filtration rate (eGFR MDRD formula) change from baseline

Participating in This Clinical Trial

Inclusion Criteria

  • Age > 18 years – Proteinuria > 1 g/d by urine protein/creatinine ratio (UP/C) or 24 hour urine collection – If treated with an angiotensin-converting-enzyme inhibitor (ACEi) or Angiotensin II receptor blockers (ARB), must be on a stable dose for at least 2 weeks prior to enrollment – Newly diagnosed recurrent focal and segmental glomerulosclerosis (FSGS), or current/previous treatment of recurrent FSGS with no evidence of at least a partial response as defined by one or more of the following: 1. Recurrent FSGS confirmed by renal transplant biopsy (FSGS on light microscopy and/or foot process effacement on electron microscopy), with FSGS as the primary disease confirmed by native renal biopsy prior to transplant 2. FSGS confirmed by renal transplant biopsy (FSGS on light microscopy and/or foot process effacement on electron microscopy), within 18 months post transplant 3. Patients at any time period post transplant with an established diagnosis of recurrent FSGS in the first 18 months post transplant who did not respond to conventional therapy as defined by persistent proteinuria of > 3 g/d by UP/C or 24 hour urine collection Exclusion Criteria:

  • Lactation, pregnancy or refusal of birth control in women of childbearing potential – Infection with human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or parvovirus B-19 – Malignancy (with the exception of treated and cured basal cell or squamous cell carcinoma) – Evidence of diabetic nephropathy, transplant glomerulopathy or other pathologies that could be associated with secondary FSGS on renal transplant biopsy – Non-renal organ transplant (with the exception of pancreas transplant) – Contraindication to receiving Acthar®

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of North Carolina, Chapel Hill
  • Collaborator
    • Mallinckrodt
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Karin True, MD, Principal Investigator, University of North Carolina, Chapel Hill

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