IRB Number:

08-006328

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This pilot study is aimed at demonstrating the effectiveness of ACTH (H.P. Achtar Gel) on the lipid profile and proteinuria in participants with membranous nephropathy. 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 U.S. 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 membranous nephropathy. However, the most adequate dose to use has not been adequately assessed. This is the reason for conducting this research study.

Who is Eligible to Participate in the Study?

Inclusion Criteria
-- Idiopathic membranous nephropathy with diagnostic biopsy performed less than 36 months from the time of dose randomization
-- Age >18 years
-- 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
-- Proteinuria as measured by Uprot/Ucr >4.0 on a spot sample aliquot from a 24-hour urine collection
-- Estimated GFR >40mL/min/1.73m2 while taking ACEi/ARB therapy

Exclusion Criteria
-- Estimated GFR <40mL/min/1.73m2 or serum creatinine >2.0mg/dL
-- Renal biopsy showing more than 30 percent glomerulosclerosis and/or tubular atrophy
-- Patients must be off glucocorticoid, calcineurin inhibitors (cyclosporin A, tacrolimus) or mycophenolic mofetil for >1 month, and alkylating agents or rituximab for >6 months
-- Resistance to the following immunosuppressive routines e.g. steroids alone, calcineurin inhibitors +/- steroids, cytotoxic agents +/- steroids
-- Patients with active infections or secondary causes of membranous nephropathy
-- Type 1 or 2 diabetes mellitus
-- Pregnancy or nursing
-- Acute renal vein thrombosis documented prior to entry by renal US or CT scan and requiring anticoagulation therapy

Minimum Age:

18

What is Involved With this Study?

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.

How long will the Study run?

You will be in the study for a maximum of 7 months and will have at least 10 study visits to the Mayo Clinic.

Who can I Contact for Additional Information on this Trial?

Lori Riess
507-266-1047

Shirley Jennison
507-255-0231

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 02/16/2009