Viewing Study NCT01021540



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Last Modification Date: 2024-10-26 @ 10:13 AM
Study NCT ID: NCT01021540
Status: COMPLETED
Last Update Posted: 2011-07-14
First Post: 2009-11-25

Brief Title: Prospective Study Evaluating the Effect of Repository Corticotropin in the Treatment of Various Nephrotic Syndromes
Sponsor: Arizona Kidney Disease and Hypertension Center
Organization: Arizona Kidney Disease and Hypertension Center

Study Overview

Official Title: Prospective Study Evaluating the Effect of Repository Corticotropin in the Treatment of Various Nephrotic Syndromes
Status: COMPLETED
Status Verified Date: 2011-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ACTH
Brief Summary: To determine if HP Acthar Gel repository corticotrophin has the same anti-proteinuric effects seen with the synthetic ACTH analogue in Europe
Detailed Description: Synthetic ACTH Synacthen Depot has been used in the treatment of Nephrotic Syndrome in Europe It has been proven effective in treating idiopathic membranous nephropathy and other various diagnoses involving the kidneys However Synacthen is not available in the United States The only preparation available is the HP Acthar Gel repository corticotrophin which has been widely used in the treatment of infantile spasms and has been available longer than Synacthen Therefore we are conducting this study to determine if HP Acthar Gel repository corticotrophin is as effective in reducing protein in the urine as seen in synthetic ACTH in Europe

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None