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

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ClinicalTrials.gov Identifier: NCT00805753
Recruitment Status : Completed
First Posted : December 10, 2008
Last Update Posted : October 13, 2014
Information provided by (Responsible Party):
Fernando Fervenza, Mayo Clinic

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
Idiopathic Membranous Nephropathy Drug: ACTH Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : January 2009
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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 Name: 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 Name: H.P. Acthar Gel

Primary Outcome Measures :
  1. Change in proteinuria [ Time Frame: baseline, 3 months ]
  2. Change in LDL cholesterol, HDL cholesterol, and triglycerides [ Time Frame: baseline, 3 months ]
  3. Change in side effects/toxicity [ Time Frame: baseline, 3 months ]

Secondary Outcome Measures :
  1. Number of subjects with CR or PR [ Time Frame: 3 months ]
  2. The effect of maximizing angiotensin II blockade on proteinuria [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805753

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M5R 0A3
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Fernando C Fervenza, M.D., Ph.D Mayo Clinic
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fernando Fervenza, M.D., Ph.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00805753    
Other Study ID Numbers: 08-006328
First Posted: December 10, 2008    Key Record Dates
Last Update Posted: October 13, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, Membranous
Urologic Diseases
Autoimmune Diseases
Immune System Diseases