Prospective Study Evaluating the Effect of Repository Corticotropin in the Treatment of Various Nephrotic Syndromes (ACTH)

To determine if H.P. Acthar Gel (repository corticotrophin) has the same anti-proteinuric effects seen with the synthetic ACTH analogue in Europe.

Study Overview

• Status: Completed
• Conditions: Nephrotic Syndromes
• Intervention / Treatment: Drug: Repository corticotrophin

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 H.P. 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 H.P. Acthar Gel (repository corticotrophin) is as effective in reducing protein in the urine as seen in synthetic ACTH in Europe.

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • AKDHC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Nephrotic Syndrome with a minimal of 3.5grams of protein per 24 hr period, measured via either 24hr urine collection or spot protein to creatinine ratio.
• Males and post-menopausal, surgically sterile, or non-lactating and non-pregnant females using adequate contraception
• Biopsy proven diagnosis of nephrotic syndrome due to Lupus glomerulonephritis, Membranous nephropathy, Focal segmental glomerulosclerosis, Minimal Change disease, Diabetic nephropathy (type 2)or IgA nephropathy.
• Greater than 18 years of age
• Willing and able to give informed consent
• Diabetics are on insulin or willing to start insulin during the study

Exclusion Criteria:

• Previous intolerance to native ACTH or proteins of porcine origin
• History of scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of peptic ulcer, primary adrenocortical insufficiency or adrenocortical hyperfunction.
• Expected to begin renal replacement therapy or receive a transplant within the next year.
• Recent cardiovascular event within 3 months of screening including: Myocardial Infarction, CVA, TIA, New York Heart Association Functional Class III or IV failure, Obstructive valvular heart disease, or hypertrophic cardiomyopathy, second or third degree atrioventricular block not successfully treated with a pacemaker.
• History of HIV
• Know peptic ulcer disease.
• SBP> 160 or DBP > 100 at time of enrollment
• New diagnosis of cancer or recurrent cancer within 2 years of screening
• History of alcohol or drug abuse within 12 months of study entry.
• Receipt of any investigational drug within 30 days of enrollment.
• Anticipated major surgery during trial period
• Psychiatric disorder that interferes with the patient's ability to comply with the protocol.
• Inability to cooperate with study personnel or history of noncompliance to medical management
• Active infection within 1 month of screening
• Poorly controlled diabetes with an HbA1C > 10%
• Type 1 diabetes mellitus

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Acthar has the same anti-proteinuric effects in a wide range of glomerulonephropaties as seen with synthetic ACTH (Synacthen) in Europe	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Acthar has similar anti-lipid effects as seen with Synacthen.	6 months

Collaborators and Investigators

• Sponsor: Arizona Kidney Disease and Hypertension Center
• Investigators: Principal Investigator: Sungchun Lee, M.D., Arizona Kidney Disease and Hypertension Center

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: November 25, 2009
• First Submitted That Met QC Criteria: November 27, 2009
• First Posted (Estimate): November 30, 2009

Study Record Updates

• Last Update Posted (Estimate): July 14, 2011
• Last Update Submitted That Met QC Criteria: July 13, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Nephritis,Nephropathy
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease; Syndrome; Nephrotic Syndrome; Nephrosis; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenocorticotropic Hormone
• Other Study ID Numbers: 2009003