Idiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTH
NCT01155141 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2014-09-01
Summary
FSGS is an immunologic disorder wherein circulating immune proteins cause damage to the kidneys and progressive injury and scarring. Corticosteroid therapy is occasionally, but not nearly universally, successful in reducing proteinuria, and when patients respond, they have a favorable prognosis. The investigators believe that ACTH therapy (H.P. Acthar Gel) can provide a more rapid, well tolerated reduction in glomerular injury.
Conditions
Interventions
- DRUG
-
H.P. Acthar Gel
Patients were treated with 40 units subcutaneously (SC) weekly for 2 weeks, then dose increased to 80 units SC weekly for 2 weeks followed by 80 units SC twice weekly to complete 16 weeks of therapy.
Sponsors & Collaborators
-
Mallinckrodt
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Richard Lafayette · Stanford University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 16 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-09-30
- Primary Completion
- 2014-01-31
- Completion
- 2014-01-31
Countries
- United States
Study Locations
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