FSGS, Renal Transplantation, Kidney Transplantation
Conditions
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.
Interventions
DRUGActhar
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).
Sponsors
Mallinckrodt
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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®
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of patients with proteinuria | 24 and 52 weeks | partial and complete remission of proteinuria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed