CLINICAL TRIALS PROFILE FOR ACTHAR GEL-SYNTHETIC

All Clinical Trials for Acthar Gel-synthetic

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01021540 ↗	Prospective Study Evaluating the Effect of Repository Corticotropin in the Treatment of Various Nephrotic Syndromes	Completed	Arizona Kidney Disease and Hypertension Center	Phase 4	2009-12-01	To determine if H.P. Acthar Gel (repository corticotrophin) has the same anti-proteinuric effects seen with the synthetic ACTH analogue in Europe.
NCT01093157 ↗	A Dose Escalation Study of Long-acting ACTH Gel in Membranous Nephropathy	Completed	Mallinckrodt	Phase 1/Phase 2	2010-02-01	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 function.There 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 (H.P. Acthar gel) will be effective in reducing proteinuria and improving lipid profile in patients with idiopathic MN.
NCT01093157 ↗	A Dose Escalation Study of Long-acting ACTH Gel in Membranous Nephropathy	Completed	University Health Network, Toronto	Phase 1/Phase 2	2010-02-01	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 function.There 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 (H.P. Acthar gel) will be effective in reducing proteinuria and improving lipid profile in patients with idiopathic MN.
NCT01129284 ↗	Treatment of Resistant Nephrotic Syndrome With ACTH Gel (ACTHAR)	Completed	Mallinckrodt	Phase 4	2009-12-01	This study will examine the safety and effectiveness of ACTHAR Gel, when used to treat 15 patients diagnosed with "treatment resistant nephrotic syndrome." Nephrotic syndrome is a group of symptoms that includes low levels of protein in the blood, swelling of tissue (edema), especially around the eyes, feet and hands; and high plasma levels of cholesterol. It is caused by a variety of diseases and underlying disorders that damage the kidneys, resulting in excessive excretion of protein in the urine. These diseases damage the glomeruli, which are small blood vessels that filter wastes and excess water from the blood and pass them into the bladder as urine. As a result of protein loss in the urine, the blood is deficient in protein. Normal amounts of blood protein are needed to help regulate fluid throughout the body. Protein in the blood normally draws water from the tissues and into the bloodstream. When blood protein levels are low, the normal movement of water is reversed, and fluid is drawn from the blood and accumulates in the tissues. This excess tissue fluid causes the swelling and puffiness (edema) that is a symptom of nephrotic syndrome. Nephrotic syndrome is described as "treatment resistant" when a patient fails to achieve a sustained partial or complete remission after treatment with at least two first line therapies. The goal of this study is to determine whether injections of ACTHAR Gel (an FDA approved treatment for nephrotic syndrome) over a six month period will lead to a correction of treatment resistant nephrotic syndrome in these patients.
NCT01129284 ↗	Treatment of Resistant Nephrotic Syndrome With ACTH Gel (ACTHAR)	Completed	Columbia University	Phase 4	2009-12-01	This study will examine the safety and effectiveness of ACTHAR Gel, when used to treat 15 patients diagnosed with "treatment resistant nephrotic syndrome." Nephrotic syndrome is a group of symptoms that includes low levels of protein in the blood, swelling of tissue (edema), especially around the eyes, feet and hands; and high plasma levels of cholesterol. It is caused by a variety of diseases and underlying disorders that damage the kidneys, resulting in excessive excretion of protein in the urine. These diseases damage the glomeruli, which are small blood vessels that filter wastes and excess water from the blood and pass them into the bladder as urine. As a result of protein loss in the urine, the blood is deficient in protein. Normal amounts of blood protein are needed to help regulate fluid throughout the body. Protein in the blood normally draws water from the tissues and into the bloodstream. When blood protein levels are low, the normal movement of water is reversed, and fluid is drawn from the blood and accumulates in the tissues. This excess tissue fluid causes the swelling and puffiness (edema) that is a symptom of nephrotic syndrome. Nephrotic syndrome is described as "treatment resistant" when a patient fails to achieve a sustained partial or complete remission after treatment with at least two first line therapies. The goal of this study is to determine whether injections of ACTHAR Gel (an FDA approved treatment for nephrotic syndrome) over a six month period will lead to a correction of treatment resistant nephrotic syndrome in these patients.

Clinical Trial Conditions for Acthar Gel-synthetic

Condition Name

Condition Name for Acthar Gel-synthetic
Intervention	Trials
Glomerulonephritis	1
Nephrotic Syndromes	1
Treatment Resistant Nephrotic Syndrome	1

Condition MeSH

Condition MeSH for Acthar Gel-synthetic
Intervention	Trials
Nephrotic Syndrome	2
Nephrosis	2
Syndrome	2
Glomerulonephritis, Membranous	1

Clinical Trial Locations for Acthar Gel-synthetic

Trials by Country

Trials by Country for Acthar Gel-synthetic
Location	Trials
United States	2
Canada	1

Trials by US State

Trials by US State for Acthar Gel-synthetic
Location	Trials
New York	1
Arizona	1

Clinical Trial Progress for Acthar Gel-synthetic

Clinical Trial Phase

Clinical Trial Phase for Acthar Gel-synthetic
Clinical Trial Phase	Trials
Phase 4	2
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for Acthar Gel-synthetic
Clinical Trial Phase	Trials
Completed	3

Clinical Trial Sponsors for Acthar Gel-synthetic

Sponsor Name

Sponsor Name for Acthar Gel-synthetic
Sponsor	Trials
Mallinckrodt	2
Arizona Kidney Disease and Hypertension Center	1
University Health Network, Toronto	1

Sponsor Type

Sponsor Type for Acthar Gel-synthetic
Sponsor	Trials
Other	3
Industry	2