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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Nephrotic Syndromes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Repository corticotrophin

Acthar 80 IU SQ once a week and titrated up to twice a week

Intervention Type DRUG

Other Intervention Names

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H.P. Acthar Gel

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No