CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 15 enrolled
Drug / intervention
H.P. Acthar Geldrug
Likely dose
H.P. Acthar Gel 40 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01155141
NCT01155141Phase 4Completed
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Idiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTH

Stanford University·interventional·Posted Jul 1, 2010·Updated Sep 1, 2014

In Brief

A Phase 4 clinical trial evaluating H.P. Acthar Gel for Kidney Diseases. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Diseases
CountriesUnited States
CollaboratorsMallinckrodt

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 1, 2010
Enrollment StartSep 1, 2009
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 16.0 years ago

Interventions

H.P. Acthar Geldrug

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.