Acthar for Treatment of Post-transplant FSGS

Phase 4

Withdrawn

• Conditions: FSGS; Renal Transplantation; Kidney Transplantation
• Interventions: Drug: Acthar

• Registration Number: NCT02399462
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-08
• Study First Submitted QC: 2015-03-20
• Study First Posted: 2015-03-26
• Study Start: 2021-03
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-26
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Drug Arm	Acthar	Acthar SC injections

Primary Outcome Measures

Name	Time	Method
number of patients with proteinuria	24 and 52 weeks	partial and complete remission of proteinuria

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States