Ignite Creation Date:
2024-05-05 @ 10:24 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01093157
Status:
COMPLETED
Last Update Posted:
2017-05-04
First Post:
2010-03-24
Brief Title:
A Dose Escalation Study of Long-acting ACTH Gel in Membranous Nephropathy
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Dose-finding Pilot Study of ACTH Adrenocorticotropic Hormone on the Proteinuria and Serum Lipoprotein Profile in Patients With Idiopathic Membranous Nephropathy MN
Status:
COMPLETED
Status Verified Date:
2013-01
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:
None
Brief Summary:
Membranous Nephropathy MN is an immune-mediated kidney disease that affects the glomerulus or the filter that removes toxins from the blood Damage to the membrane that separates blood from urine results in loss of protein into the urine proteinuria and in some cases loss of kidney functionThere is no standard specific treatment for MN
ACTH has a pronounced lipid-lowering effect in healthy individuals in steroid-treated patients with renal disease and in hemodialysis patients Some studies suggest that prolonged synthetic ACTH therapy may represent an effective therapy in patients with idiopathic MN more extensive randomized studies with longer follow-up are needed before therapeutic recommendations can be made
We propose to do a pilot study to test the hypothesis that biologic ACTH a slow-release formulation of corticotropin extracted from porcine pituitary glands HP Acthar gel will be effective in reducing proteinuria and improving lipid profile in patients with idiopathic MN
ACTH has a pronounced lipid-lowering effect in healthy individuals in steroid-treated patients with renal disease and in hemodialysis patients Some studies suggest that prolonged synthetic ACTH therapy may represent an effective therapy in patients with idiopathic MN more extensive randomized studies with longer follow-up are needed before therapeutic recommendations can be made
We propose to do a pilot study to test the hypothesis that biologic ACTH a slow-release formulation of corticotropin extracted from porcine pituitary glands HP Acthar gel will be effective in reducing proteinuria and improving lipid profile in patients with idiopathic MN
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Health Canada | REGISTRY | Health Canada 4727-883-23 C control 131403 | None |