Clinical Trial: Adrenocorticotropic Hormone in Membranous Nephropathy

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Changes in Autoreactive Memory B Cells as Biomarker of Response to Adrenocorticotropic Hormone in Patients With Membranous Nephropathy

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Icahn School of Medicine at Mount Sinai

Current Primary Outcome: Remission of proteinuria [ Time Frame: baseline and 12 months ]

Change in proteinuria at baseline versus after 12 months of treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 24h Proteinuria [ Time Frame: 12 months ]
    Protein concentration in the urine.
  • Estimated Glomerular Filtration Rate (GFR) [ Time Frame: 12 months ]
    GFR measures kidney function.
  • Anti-PLA2R antibodies levels [ Time Frame: 12 months ]
    blood levels
  • Anti-PLA2R memory B cells [ Time Frame: 12 months ]
    blood levels
  • CD4+CD25+CD127lowFoxP3+ T cell [ Time Frame: 12 months ]
    blood levels - one single cell subset identified by different markers


Original Secondary Outcome:

  • 24h Proteinuria [ Time Frame: 12 months ]
    Protein concentration in the urine.
  • Estimated Glomerular Filtration Rate (GFR) [ Time Frame: 12 months ]
  • Anti-PLA2R antibodies levels [ Time Frame: 12 months ]
    blood levels
  • Anti-PLA2R memory B cells [ Time Frame: 12 months ]
    blood levels
  • CD4+CD25+CD127lowFoxP3+ T cell [ Time Frame: 12 months ]
    blood levels - one single cell subset identified by different markers


Information By: Icahn School of Medicine at Mount Sinai

Dates:
Date Received: January 17, 2017
Date Started: May 2017
Date Completion: February 2019
Last Updated: May 2, 2017
Last Verified: May 2017