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

This study is currently recruiting participants.
Verified November 2012 by Mayo Clinic
Sponsor:
Collaborator:
Questcor Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Fernando Fervenza, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00805753
First received: December 9, 2008
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
Idiopathic Membranous Nephropathy
 Drug: ACTH
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in proteinuria [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • change in LDL cholesterol, HDL cholesterol, and triglycerides [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • side effects/toxicity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • CR or PR [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • The effect of maximizing angiotensin II blockade on proteinuria [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00805753

Contacts
Contact: Lori Riess 507-266-1047 riess.lori@mayo.edu
Contact: Shirley Jennison 507-255-0231 jennison.shirley@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Lori Riess     507-266-1047     riess.lori@mayo.edu    
Contact: Shirley Jennison     507-255-0231     jennison.shirley@mayo.edu    
Principal Investigator: Fernando C. Fervenza, M.D., Ph.D.            
Sponsors and Collaborators
Mayo Clinic
Questcor Pharmaceuticals, Inc.
Investigators
Principal Investigator: Fernando C Fervenza, M.D., Ph.D Mayo Clinic
  More Information

Additional Information:
Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Fernando Fervenza, M.D., Ph.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00805753     History of Changes
Other Study ID Numbers: 08-006328
Study First Received: December 9, 2008
Last Updated: November 6, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glomerulonephritis, Membranous
Kidney Diseases
Glomerulonephritis
Nephritis
Urologic Diseases
Autoimmune Diseases
 Immune System Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013