Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ABR: NL22482.091.08 | |||
| CMO: 2008/77 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dutch Kidney Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether treatment with long-acting synthetic adrenocorticotropic hormone is in the treatment of patients with idiopathic membranous nephropathy and high for renal failure.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | In this open-label study all patients included are treated in the experimental group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tetracosactide hexacetaat | Drug | Intramuscular injections with tetracosactide hexacetaat (Synacthen Depot) 1ml a 1mg/ml. Treatment for 9 months with an increasing dosage from once per 2 weeks to twice a week. |
| Measure | Description | Time Frame |
|---|---|---|
| Attainability of ACTH therapy with intramuscular injections twice a week for a period of 9 months, measured as the percentage of injections that has been received in line with the treatment schedule. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of treatment with ACTH: number of remissions of proteinuria at the end of treatment | 9 and 24 months |
Not provided
Inclusion Criteria:
Biopsy-proven idiopathic membranous nephropathy.
Nephrotic syndrome: proteinuria > 3.5 g/day and serum albumine < 30 g/l
Normal or mildly impaired renal function (eGFR > 60 ml/min, MDRD formula)
High risk for renal failure: beta-2-microglobulin excretion > 500 ng/min
Relative contra-indication for cyclophosphamide treatment:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jack FM Wetzels, M.D.Ph.D. | Department of Nephrology, Radboud University | Study Director |
| Julia M Hofstra, M.D. | Department of Nephrology, Radboud University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University | Nijmegen | 6500 HB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26562836 | Derived | van de Logt AE, Beerenhout CH, Brink HS, van de Kerkhof JJ, Wetzels JF, Hofstra JM. Synthetic ACTH in High Risk Patients with Idiopathic Membranous Nephropathy: A Prospective, Open Label Cohort Study. PLoS One. 2015 Nov 12;10(11):e0142033. doi: 10.1371/journal.pone.0142033. eCollection 2015. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015433 | Glomerulonephritis, Membranous |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C006418 | adrenocorticotropin zinc |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |