Nephrotic Syndromes Clinical Trial
— ACTHOfficial title:
Prospective Study Evaluating the Effect of Repository Corticotropin in the Treatment of Various Nephrotic Syndromes
To determine if H.P. Acthar Gel (repository corticotrophin) has the same anti-proteinuric effects seen with the synthetic ACTH analogue in Europe.
| Status | Completed |
| Enrollment | 18 |
| Est. completion date | October 2010 |
| Est. primary completion date | October 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | AKDHC | Phoenix | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Arizona Kidney Disease and Hypertension Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Acthar has the same anti-proteinuric effects in a wide range of glomerulonephropaties as seen with synthetic ACTH (Synacthen) in Europe | 6 months | No | |
| Secondary | Acthar has similar anti-lipid effects as seen with Synacthen. | 6 months | No |