This pilot study is aimed at demonstrating the effectiveness of ACTH (H.P. Acthar Gel) on the lipid profile and proteinuria in participants with MN. ACTH or adrenocorticotrophin is a hormone produced by the pituitary gland (a gland at the base of your brain) that is involved in stimulating your adrenal glands to secrete a number of steroid products (e.g. cortisol, aldosterone, corticosterone, and others) that are important in keeping you alive. The drug used in this study has been approved by the Food and Drug Administration (FDA) for routine clinical use in the treatment of patients with proteinuria and patients with idiopathic nephrotic syndrome such as idiopathic MN. However, the most adequate dose to use has not been adequately assessed. This is the reason for conducting this research study.
Inclusion Criteria:
1. Idiopathic MN with diagnostic biopsy performed less than 36 months from the time of dose randomization.
2. Age > 18 years.
3. Patients need to be treated with an ACEI and/or ARB, for at least 3 months prior to ACTH treatment and have adequately controlled blood pressure
4. Proteinuria of >4.0 on a 24-hour urine collection.
5. Estimated GFR >40 ml/min/1.73m2 while taking ACEI/ARB therapy.
Exclusion Criteria:
1. Age <18 years.
2. Estimated GFR <40 ml/min/1.73m2, or serum creatinine >2.0 mg/dl.
3. Renal biopsy showing more than 30% glomerulosclerosis and/or tubular atrophy.
4. Patient must be off glucocorticoid, calcineurin inhibitors (cyclosporin A, tacrolimus) or mycophenolic mofetil for >1 month, and alkylating agents or rituximab for >6 months.
5. Resistance to the following immunosuppressive routines e.g. steroids alone, calcineurin inhibitors plus or minus steroids, cytotoxic agents plus or minus steroids.
6. Patients with active infections or secondary causes of MN.
7. Type 1 or 2 diabetes mellitus.
8. Pregnancy or nursing.
9. Acute renal vein thrombosis documented prior to entry by renal US or CT scan and requiring anticoagulation therapy.
Screening
You will have a physical examination and routine blood and urine tests as well as collect your urine for 24 hours to determine if you are eligible to take part in the study.
Treatment Phase
You will be put in one of two groups by chance (as in the flip of a coin) to receive ACTH at the dose of either 40 units (group 1) or 80 units (group 2), subcutaneously (under the skin), at 8 a.m. to 9 a.m. The dose of ACTH will be increased from one injection every other week to two injections per week during a period of 12 weeks. Once administration of ACTH is stopped, you will start on prednisone 10mg a day for one week. The dose will continue to be tapered down by 1 mg per week until stopped. The reason for the use of oral prednisone is to avoid potential development of adrenal insufficiency.
You will be in the study for a maximum of 7 months and will have at least 10 study visits to the Mayo Clinic.
Last updated: 11/06/2012
NCT ID: NCT00805753
IRB Number:08-006328
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