Trial | NCT01021540  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    corticotropin ...

  • Study Participants

    18
To determine if H.P. Acthar Gel (repository corticotrophin) has the same anti-proteinuric effects seen with the synthetic ACTH analogue in Europe.
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 Started
Dec 31
2009
Primary Completion
Oct 31
2010
Study Completion
Oct 31
2010
Last Update
Jul 14
2011
Estimate

Drug Repository corticotrophin

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

  • Other names: H.P. Acthar Gel

Criteria 

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
No Results Posted