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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repository corticotrophin | Drug | Acthar 80 IU SQ once a week and titrated up to twice a week |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acthar has similar anti-lipid effects as seen with Synacthen. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sungchun Lee, M.D. | Arizona Kidney Disease and Hypertension Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKDHC | Phoenix | Arizona | 85032 | United States |
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| ID | Term |
|---|---|
| D009404 | Nephrotic Syndrome |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D009401 | Nephrosis |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |