Dose-Finding Pilot Study of ACTH in Patients With Idiopathic Membranous Nephropathy
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Nephrology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/27/2013 |
| Start Date: | January 2009 |
| End Date: | December 2013 |
| Contact: | Lori Riess |
| Email: | riess.lori@mayo.edu |
| Phone: | 507-266-1047 |
A Dose-Finding Pilot Study of ACTH on the Serum Lipoprotein Profile and Proteinuria in Patients With Idiopathic Membranous Nephropathy (MN)
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.
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