Acthar for Treatment of Post-transplant FSGS

Study Overview
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Brief Summary
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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.

Official Title
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Acthar for Treatment of Post-transplant FSGS

Conditions
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FSGS, Renal Transplantation, Kidney Transplantation

Intervention / Treatment
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* Drug: Acthar


Participation Criteria
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Eligibility Criteria
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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: 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 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®

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Drug Arm<br>Acthar SC injections | Drug: Acthar<br>* 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).<br>* Other names: ACTH (adrenocorticotropic hormone ), corticotropin;|

What is the study measuring?
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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 |