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Changes in Autoreactive Memory B Cells as Biomarker of Response to Adrenocorticotropic Hormone in Patients With Membranous Nephropathy (NCT03025828)

The purpose of this study is to evaluate the effect of adrenocorticotropic hormone (ACTH, Acthar) on the loss of proteins in the urine (proteinuria) in patients with membranous nephropathy. Acthar is a hormone that stimulates steroid production from small glands above the kidneys. It has direct protective effects on the kidney and is currently approved by the FDA to treat kidney disorders associated with proteins in the urine, but the mechanisms of action are not entirely understood and will be studied in the present trial.
  • Drug: ACTHar
    for 6 months
    • ACTH
    • Acthar Injectable Product
Ages eligible for Study
18 Years to 70 Years
Genders eligible for Study
All
Accepts Healthy Volunteers
No
Inclusion Criteria:
  • Age 18 to 70 years
  • Free of immunosuppression for at least 3 months
  • Capability of understanding the purpose of the study
  • Written informed consent
Exclusion Criteria:
  • epidermal growth factor receptor (eGFR) < 30ml/min/1.73m2
  • Kidney Transplant
  • Secondary MN (defined on the basis of clinical criteria)
  • Type 1 or Type 2 diabetes mellitus (prior diagnosis of gestational diabetes mellitus is not an exclusion)
  • History of previous use of Acthar for treatment of nephrotic syndrome
  • Prior sensitivity to Acthar or other porcine protein products
  • Contraindication to Acthar per Prescribing Information
  • Planned treatment with live or live attenuated vaccines once enrolled in the study
  • More than three previous treatment regiments
  • Participation to other clinical trials over the previous 12 months
  • History of cancer, except carcinoma in situ and treated basal and squamous cell carcinomas
  • Pregnancy
  • Lactation
  • Current substance abuse
  • Any clinically relevant condition that might affect study participation and/or study results
Patients with membranous nephropathy and nephrotic syndrome will be treated with ACTH for 6 months. Proteinuria remission at 12 months will be the primary endpoint. Different biomarkers including anti-PLA2R autoantibodies, circulating regulatory T cells, and autoreactive memory B cells will be serially measured to identify predictors of response to therapy.

1 locations

United States (1)
  • Icahn School of Medicine at Mount Sinai
    recruiting
    New York, New York, United States, 10029
Status:
recruiting
Type:
Interventional
Phase:
Start:
30 June, 2017
Updated:
15 June, 2017
Participants:
25
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