Status:
COMPLETED
Idiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTH
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Mallinckrodt
Conditions:
Kidney Diseases
Eligibility:
All Genders
16-65 years
Phase:
PHASE4
Brief 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,...
Detailed Description
EXPERIMENTAL TREATMENT: Patients with biopsy proven FSGS will be treated with ACTH in an open-label pilot study of tolerability and efficacy. The investigators will recruit 18-20 patients to complete ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01155141
Start Date
September 1 2009
End Date
January 1 2014
Last Update
September 1 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University School of Medicine
Stanford, California, United States, 94305