Acthar for Treatment of Post-transplant FSGS

Kidney Transplantation Clinical Trial

Official title:

Acthar for Treatment of Post-transplant FSGS

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02399462
• Other study ID #: 15-0999
• Secondary ID: ACTH-101
• Status: Withdrawn
• Phase: Phase 4
• Start date: March 2021
• Est. completion date: July 31, 2021

Study information

• Verified date: August 2021
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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®

Related Conditions & MeSH terms

• FSGS
• Kidney Transplantation
• Renal Transplantation

Intervention

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).

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with proteinuria	partial and complete remission of proteinuria	24 and 52 weeks
Secondary	Graft loss	graft loss defined by return to dialysis, re-transplant or death during study period	during study period
Secondary	eGFR change	estimated Glomerular filtration rate (eGFR MDRD formula) change from baseline	weeks 4,8,12,16,20 and 24