Acthar for Treatment of Post-transplant FSGS

Withdrawn before enrolling · Phase 4

Conditions studied: FSGS, Renal Transplantation, Kidney Transplantation

In brief

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.

Key facts

Study ID

NCT02399462

Run by

University of North Carolina, Chapel Hill

People needed

0

Starts

2021-03-01

Expected to finish

2021-07-31

Last updated by the study team

2021-08-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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
• FSGS confirmed by renal transplant biopsy (FSGS on light microscopy and/or foot process effacement on electron microscopy), within 18 months post transplant
• 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

You may not qualify if…

• 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®

Where it is running

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

Full record on ClinicalTrials.gov

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