CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 63 enrolled
Drug / intervention
Acthar Geldrug
Likely dose
Not stated in 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/NCT02633046
NCT02633046Phase 4Completed

Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic Focal Segmental Glomerulosclerosis: A Prospective Study of Acthar (PODOCYTE)

Mallinckrodt ARD LLC·interventional·Posted Dec 17, 2015·Updated Aug 4, 2021

In Brief

A Phase 4 clinical trial evaluating Acthar Gel for Idiopathic Focal Segmental Glomerulosclerosis. Completed, enrolled 63 participants across 47 sites in 7 countries.

Detailed Summary

Focal segmental glomerulosclerosis (FSGS) is a condition that harms the kidney "filters" that remove waste from the blood. Proteins are supposed to stay in the blood. Damaged "filters" let protein get into the kidney. FSGS is a serious condition that can lead to kidney failure. The only treatment for kidney failure is dialysis or kidney transplant. Proteinuria means too much protein came through the kidneys into the urine. If the doctor cannot figure out what is causing the problem, it is primary (idiopathic) FSGS. This kind of FSGS is very hard to treat. This study will test Acthar in patients with this condition who have not responded to other treatments. It primarily investigates how well the therapy is tolerated by the patients and how well they respond to this treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Chile, Mexico, Peru, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 17, 2015
Enrollment StartOct 10, 2016
Primary CompletionAug 27, 2020
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 10.5 years ago

Interventions

Acthar Geldrug

Acthar Gel 80 U/mL solution for subcutaneous injection