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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00805753
Collaborator
Mallinckrodt (Industry)
20
Enrollment
2
Locations
2
Arms
68
Duration (Months)
10
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Dose-Finding Pilot Study of ACTH on the Serum Lipoprotein Profile and Proteinuria in Patients With Idiopathic Membranous Nephropathy (MN)
Study Start Date :
Jan 1, 2009
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Sep 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm 1 ACTH 40 units

Receive ACTH at the dose of 40 units sub-cutaneously for up to 12 weeks. If at day 91 no response has been shown, you will have the option to increase the dose of ACTH to 80 units for up to an additional 120 days.

Drug: ACTH
comparison of different dosages of drug
Other Names:
  • H.P. Acthar Gel

    		•
    Active Comparator: Arm 2 ACTH 80 units

    Receive ACTH at the dose of 80 units sub-cutaneously for up to 12 weeks.

    Drug: ACTH
    comparison of different dosages of drug
    Other Names:
  • H.P. Acthar Gel

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in proteinuria [baseline, 3 months]

    2. Change in LDL cholesterol, HDL cholesterol, and triglycerides [baseline, 3 months]

    3. Change in side effects/toxicity [baseline, 3 months]

    Secondary Outcome Measures

    1. Number of subjects with CR or PR [3 months]

    2. The effect of maximizing angiotensin II blockade on proteinuria [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905
    2 University of Toronto Toronto Ontario Canada M5R 0A3

    Sponsors and Collaborators

    • Mayo Clinic
    • Mallinckrodt

    Investigators

    • Principal Investigator: Fernando C Fervenza, M.D., Ph.D, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fernando Fervenza, M.D., Ph.D., Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT00805753
    Other Study ID Numbers:
    • 08-006328
    First Posted:
    Dec 10, 2008
    Last Update Posted:
    Oct 13, 2014
    Last Verified:
    Oct 1, 2014
    Additional relevant MeSH terms:
    Kidney Diseases
    Glomerulonephritis, Membranous

    Study Results

    No Results Posted as of Oct 13, 2014