Acthar for Treatment of Post-transplant FSGS

• Register: ClinicalTrials.gov
• Last refreshed on: 7 September 2021
• Main ID: NCT02399462
• Date of registration: 08/01/2015
• Prospective Registration: Yes
• Primary sponsor: University of North Carolina, Chapel Hill
• Public title: Acthar for Treatment of Post-transplant FSGS
• Scientific title: Acthar for Treatment of Post-transplant FSGS
• Date of first enrolment: March 2021
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02399462
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Karin True, MD
• Affiliation: University of North Carolina, Chapel Hill

Key inclusion & exclusion 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®



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Kidney Transplantation

FSGS

Renal Transplantation

Intervention(s)

Drug: Acthar

Primary Outcome(s)

number of patients with proteinuria [Time Frame: 24 and 52 weeks]

Secondary Outcome(s)

eGFR change [Time Frame: weeks 4,8,12,16,20 and 24]

Graft loss [Time Frame: during study period]

Secondary ID(s)

15-0999

ACTH-101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mallinckrodt