Adrenocorticotropic Hormone in Membranous Nephropathy

Overview

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.

Full Title of Study: “Changes in Autoreactive Memory B Cells as Biomarker of Response to Adrenocorticotropic Hormone in Patients With Membranous Nephropathy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2021

Detailed Description

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.

Interventions

  • Drug: ACTHar
    • for 6 months

Arms, Groups and Cohorts

  • Experimental: Acthar
    • Acthar will be administered subcutaneously (SC) 80 units for the first week and then 80 units twice weekly

Clinical Trial Outcome Measures

Primary Measures

  • Remission of proteinuria
    • Time Frame: baseline and 12 months
    • Change in proteinuria at baseline versus after 12 months of treatment.

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Icahn School of Medicine at Mount Sinai
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Paolo Cravedi, MD, PhD, Principal Investigator, Icahn School of Medicine at Mount Sinai
  • Overall Contact(s)
    • Paolo Cravedi, MD, PhD, 212-241-3349, paolo.cravedi@mssm.edu

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