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Trial record 1 of 1 for:    NCT03025828
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Adrenocorticotropic Hormone in Membranous Nephropathy

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ClinicalTrials.gov Identifier: NCT03025828
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Membranous Nephropathy Drug: ACTHar Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Changes in Autoreactive Memory B Cells as Biomarker of Response to Adrenocorticotropic Hormone in Patients With Membranous Nephropathy
Actual Study Start Date : March 19, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acthar
Acthar will be administered subcutaneously (SC) 80 units for the first week and then 80 units twice weekly
Drug: ACTHar
for 6 months
Other Names:
  • ACTH
  • Acthar Injectable Product




Primary Outcome Measures :
  1. Remission of proteinuria [ Time Frame: baseline and 12 months ]
    Change in proteinuria at baseline versus after 12 months of treatment.


Secondary Outcome Measures :
  1. 24h Proteinuria [ Time Frame: 12 months ]
    Protein concentration in the urine.

  2. Estimated Glomerular Filtration Rate (GFR) [ Time Frame: 12 months ]
    GFR measures kidney function.

  3. Anti-PLA2R antibodies levels [ Time Frame: 12 months ]
    blood levels

  4. Anti-PLA2R memory B cells [ Time Frame: 12 months ]
    blood levels

  5. CD4+CD25+CD127lowFoxP3+ T cell [ Time Frame: 12 months ]
    blood levels - one single cell subset identified by different markers



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03025828


Contacts
Contact: Paolo Cravedi, MD, PhD 212-241-3349 paolo.cravedi@mssm.edu
Contact: Ibeawuchi Okoroafor, MD ibeawuchi.okoroafor@mssm.edu

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Paolo Cravedi, MD, PhD    212-241-3349    paolo.cravedi@mssm.edu   
Contact: Ibeawuchi Okoroafor, MD    212-241-2954    ibeawuchi.okoroafor@mssm.edu   
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Paolo Cravedi, MD, PhD Icahn School of Medicine at Mount Sinai

Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03025828     History of Changes
Other Study ID Numbers: GCO 16-2402
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Icahn School of Medicine at Mount Sinai:
Membranous nephropathy
adrenocorticotropic hormone
ACTH
proteinuria
glomerulonephritis

Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, Membranous
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Hormones
Adrenocorticotropic Hormone
Melanocyte-Stimulating Hormones
beta-Endorphin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action