Dose-Finding Pilot Study of ACTH in Patients With Idiopathic Membranous Nephropathy

Idiopathic Membranous Nephropathy Clinical Trial

— MN  

Official title:

A Dose-Finding Pilot Study of ACTH on the Serum Lipoprotein Profile and Proteinuria in Patients With Idiopathic Membranous Nephropathy (MN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00805753
• Other study ID #: 08-006328
• Status: Completed
• Phase: Phase 1
• First received: December 9, 2008
• Last updated: October 10, 2014
• Start date: January 2009
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, Membranous
• Idiopathic Membranous Nephropathy
• Kidney Diseases

Intervention

Drug:
• ACTH
comparison of different dosages of drug

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Mallinckrodt

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in proteinuria		baseline, 3 months	No
Primary	Change in LDL cholesterol, HDL cholesterol, and triglycerides		baseline, 3 months	No
Primary	Change in side effects/toxicity		baseline, 3 months	Yes
Secondary	Number of subjects with CR or PR		3 months	No
Secondary	The effect of maximizing angiotensin II blockade on proteinuria		3 months	No