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NCT Number: NCT03025828

Adrenocorticotropic Hormone in Membranous Nephropathy

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.

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Key information

Conditions

Membranous Nephropathy Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, Membranous Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACTHar

Drug

for 6 months

Other names: ACTH, Acthar Injectable Product, Repository corticotropin injection, RCI, Acthar® Gel

Primary outcomes

  1. Change in Proteinuria

    Time frame: baseline and 12 months

    Change in proteinuria at baseline versus after 12 months of treatment as measured by urine protein/creatinine ratio

Secondary outcomes

  1. Number of Participants With Complete or Partial Remission

    Time frame: 12 months

    Complete (proteinuria reduction <500mg/24h) or partial (urinary protein excretion (P/C) <3.0 g/g (with at least 50% reduction versus baseline) in at least two consecutive visits) remission.

  2. Change in Serum Albumin

    Time frame: baseline 6 months, 12 months

    Change in serum albumin from baseline

  3. Estimated Glomerular Filtration Rate (GFR)

    Time frame: baseline and 12 months

    GFR measures kidney function.

  4. Number of Anti-PLA2R Memory B Cells

    Time frame: 12 months

    Number of anti-PLA2R memory B cells

  5. Anti-PLA2R Antibodies Levels

    Time frame: 12 months

    blood levels

    Number of anti-PLA2R memory B cells

  6. Change in CD4+CD25+CD127low T Regulatory Cells/CD4+ T Cell Ratio

    Time frame: baseline and 12 months

    blood levels - one single cell subset identified by different markers

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 20, 2017
Registry last updated
Aug 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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