Clinical trial NCT02399462: Acthar for Treatment of Post-transplant FSGS
Official title: Acthar for Treatment of Post-transplant FSGS
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: FSGS
Renal Transplantation
Kidney Transplantation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2015-03-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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®

Primary outcomes:
measure: number of patients with proteinuria
timeFrame: 24 and 52 weeks
Secondary outcomes:
measure: Graft loss
timeFrame: during study period
measure: eGFR change
timeFrame: weeks 4,8,12,16,20 and 24
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Karin True, MD
role: PRINCIPAL_INVESTIGATOR
References: