Acthar for Treatment of Post-transplant FSGS

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 Overview

• Status: Withdrawn
• Conditions: Kidney Transplantation; Renal Transplantation; FSGS
• Intervention / Treatment: Drug: Acthar

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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®

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Study Drug Arm; Acthar SC injections

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).; Other Names: ACTH (adrenocorticotropic hormone ), corticotropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients with proteinuria	partial and complete remission of proteinuria	24 and 52 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Mallinckrodt
• Investigators: Principal Investigator: Karin True, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: January 8, 2015
• First Submitted That Met QC Criteria: March 20, 2015
• First Posted (Estimate): March 26, 2015

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 26, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
• Other Study ID Numbers: 15-0999; ACTH-101 (Other Identifier: UNC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No