Acthar for Treatment of Proteinuria in Membranous Nephropathy Patients - Full Text View

Sponsor:	Questcor Pharmaceuticals, Inc.
Information provided by (Responsible Party):	Questcor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01386554

Purpose

The purpose of this study is to provide the clinician with placebo-controlled safety and efficacy data for the indicated use of Acthar in the treatment of idiopathic membranous nephropathy. Questcor has chosen to evaluate Acthar in those who are treatment-resistant with a low probability of spontaneous remission. The dose regimens selected are designed to be within the FDA approved package insert, and to provide clinically-actionable data consistent with the clinical practice of dose titration.

Condition	Intervention	Phase
Proteinuria Idiopathic Membranous Nephropathy	Drug: Repository Corticotropin Injection Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study of H.P. Acthar Gel (Acthar) in Treatment-Resistant Subjects With Persistent Proteinuria and Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy (iMN)

Resource links provided by NLM:

Drug Information available for: Corticotropin

U.S. FDA Resources

Further study details as provided by Questcor Pharmaceuticals, Inc.:

Primary Outcome Measures:

Complete or partial remission in proteinuria [ Time Frame: At Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects that have sustained complete or partial remission [ Time Frame: At Month 6 and Month 7 ] [ Designated as safety issue: No ]

Estimated Enrollment:	84
Study Start Date:	August 2011
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 0.5 mL Acthar Acthar 40 U (0.5 mL) five times per week (Monday through Friday)	Drug: Repository Corticotropin Injection Acthar given SC for 6 months (40 U fives times a week and 80 U two times a week) Other Names: H.P. Acthar Gel ACTH Gel ACTH
Placebo Comparator: 0.5 mL Placebo Placebo (0.5 mL) five times per week (Monday through Friday)	Drug: Placebo Placebo contains the same inactive ingredients as that used for H.P. Acthar Gel without the API. Placebo given SC for 6 months (40 U five times a week and 80 U two times a week).
Experimental: 1.0 mL Acthar Acthar 80 U (1.0 mL) two times per week	Drug: Repository Corticotropin Injection Acthar given SC for 6 months (40 U fives times a week and 80 U two times a week) Other Names: H.P. Acthar Gel ACTH Gel ACTH
Placebo Comparator: 1.0 mL Placebo Placebo (1.0 mL) two times per week	Drug: Placebo Placebo contains the same inactive ingredients as that used for H.P. Acthar Gel without the API. Placebo given SC for 6 months (40 U five times a week and 80 U two times a week).

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

For complete list of inclusion and exclusion criteria, please refer to contact below.

Inclusion Criteria:

A history of nephrotic syndrome due to iMN as confirmed by documented results from a renal biopsy performed within 4 years prior to screening Visit 1.
Any prior course of at least 3 months of treatment with ≥1 of the following standard therapies for iMN: alkylating agents (for example, cyclophosphamide or chlorambucil) or calcineurin inhibitors (for example, cyclosporine or tacrolimus). A subject must be followed off treatment for the same amount of time in which they were treated to evaluate for treatment response. If, after the follow-up period, it was determined that the subject did not achieve a complete or partial remission, the subject will be eligible for the study.

Exclusion Criteria:

Use of disease modifying agent within "delayed effect" window: (a) Treatment within 1 month of randomization with glucocorticoids, calcineurin inhibitors, or mycophenolic mofetil; or (b) Treatment within 6 months of randomization with rituximab
Therapies and/or medications: (a) History of previous use of Acthar for treatment of nephrotic syndrome; (b) Prior sensitivity to Acthar or other porcine protein products; (c) Chronic systemic corticosteroid use, defined as any dose of systemic corticosteroid taken for more than 4 consecutive weeks within 1 month prior to randomization visit (the use of topical, inhaled, or intra-articular corticosteroids is allowed); or (d) Planned treatment with live or live attenuated vaccines once enrolled in the study
Contraindication to Acthar per package insert: scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenal insufficiency, or adrenocortical hyperfunction. For the purpose of this study: "history" of peptic ulcer is defined as ≤6 months prior to Visit 1A.
History of Systemic Lupus Erythematosus
Type 1 or Type 2 diabetes mellitus (prior diagnosis of gestational diabetes mellitus is not an exclusion)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386554

Contacts

Contact: Jay Elliott, PhD	(513) 579-9911 ext 2032	j.elliott@medpace.com
Contact: Mary Nyberg, MBA	(443) 973-2015	mary.nyberg@questcor.com

Show 29 Study Locations

Sponsors and Collaborators

Questcor Pharmaceuticals, Inc.

Investigators

Principal Investigator:

Daniel Cattran, MD

University Health Network - Toronto General Hospital

More Information

Publications:

Bomback AS, Tumlin JA, Baranski J, Bourdeau JE, Besarab A, Appel AS, Radhakrishnan J, Appel GB. Treatment of nephrotic syndrome with adrenocorticotropic hormone (ACTH) gel. Drug Des Devel Ther. 2011 Mar 14;5:147-53.

Responsible Party:	Questcor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01386554 History of Changes
Other Study ID Numbers:	QSC01-MN-01, Control No. 151642
Study First Received:	June 29, 2011
Last Updated:	January 24, 2012
Health Authority:	United States: Institutional Review Board Canada: Health Canada Canada: Ethics Review Committee

Keywords provided by Questcor Pharmaceuticals, Inc.:

H.P. Acthar Gel
Acthar
nephrotic syndrome
idiopathic membranous nephropathy
proteinuria

Additional relevant MeSH terms:

Glomerulonephritis, Membranous
Kidney Diseases
Nephrotic Syndrome
Proteinuria
Glomerulonephritis
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases

Nephrosis
Urination Disorders
Urological Manifestations
Signs and Symptoms
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012