©2024 Stanford Medicine
Idiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTH
Not Recruiting
Trial ID: NCT01155141
Purpose
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.
Official Title
Idiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTH
Eligibility
Inclusion Criteria:
- 1. Biopsy proven FSGS
- 2. Ability to consent and complete study evaluations
- 3. Greater than 2g/day of proteinuria
- 4. No contraindications to treatment with corticosteroids or ACTH
- 5. Women of childbearing potential will agree to use effective forms of birth control
throughout this study
Exclusion Criteria:
- 1. Known secondary cause of FSGS
- 2. Receiving active immune therapy (within 90 days)
- 3. Pregnancy
- 4. Creatinine >2.5 mg/dl
- 5. Uncontrolled HTN (>180/100mm Hg)
- 6. Diabetes
- 7. Acute or chronic infection
- 8. Severe comorbidity (active coronary, cerebrovascular disease, cancer, psychiatric
disease)
- 9. Age < 16, >65 years
- 10. Evidence of untreated tuberculosis (+PPD or Ellispot Gold testing)
- 11. A known contraindication to ACTH. Corticotropin is considered contraindicated in
patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes
simplex, recent surgery, history of or the presence of a peptic ulcer, congestive
heart failure, uncontrolled hypertension, or sensitivity to proteins of porcine
origin.
Intervention(s):
drug: H.P. Acthar Gel
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Richard Lafayette
(650) 723-6248