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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 March 2021 |
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Main ID: |
NCT03025828 |
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Date of registration:
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17/01/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Adrenocorticotropic Hormone in Membranous Nephropathy
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Scientific title:
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Changes in Autoreactive Memory B Cells as Biomarker of Response to Adrenocorticotropic Hormone in Patients With Membranous Nephropathy |
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Date of first enrolment:
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March 19, 2018 |
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Target sample size:
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5 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03025828 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Paolo Cravedi, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Icahn School of Medicine at Mount Sinai |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Membranous Nephropathy
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Intervention(s)
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Drug: ACTHar
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Primary Outcome(s)
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Remission of proteinuria
[Time Frame: baseline and 12 months]
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Secondary Outcome(s)
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24h Proteinuria
[Time Frame: 12 months]
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Anti-PLA2R antibodies levels
[Time Frame: 12 months]
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Anti-PLA2R memory B cells
[Time Frame: 12 months]
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CD4+CD25+CD127lowFoxP3+ T cell
[Time Frame: 12 months]
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Estimated Glomerular Filtration Rate (GFR)
[Time Frame: 12 months]
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Secondary ID(s)
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GCO 16-2402
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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