Phase 4
N=16
Idiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTH
Kidney Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01155141 ↗Enrolled (actual)
16
Serious AEs
13.3%
Results posted
Sep 2014
Primary outcome: Primary: 24 Hour Proteinuria — 3.6; 3.8; 2.2; 3.0 g/day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- H.P. Acthar Gel (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 24 Hour Proteinuria |
3.6; 3.8; 2.2; 3.0 | — |
| PRIMARY Serum Creatinine |
1.4; 1.8; 1.8; 1.9; 2.0 | — |
| PRIMARY Protein/Creatinine Ratio |
3.1; 3.1; 2.4; 1.6 | — |
| SECONDARY eGFR |
56.0; 44.0; 37.5; 43.0; 38.0 | — |
| SECONDARY Weight |
87.5; 89.8; 94.0; 93.8; 91.3 | — |
| SECONDARY Systolic Blood Pressure |
128.0; 136.0; 136.0; 134.0; 128.0 | — |
| SECONDARY Diastolic Blood Pressure |
82.0; 85.0; 80.0; 78.0; 77.0 | — |
| SECONDARY Glucose |
95; 92.0; 93.0; 97.0; 88.0 | — |
| SECONDARY Total Cholesterol |
236.0; 215.0; 229.0; 217.0 | — |
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.
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT01155141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.