Adrenocorticotropic Hormone in Membranous Nephropathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03025828|
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : April 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Membranous Nephropathy||Drug: ACTHar||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||July 2021|
|Estimated Study Completion Date :||July 2021|
Acthar will be administered subcutaneously (SC) 80 units for the first week and then 80 units twice weekly
for 6 months
- Remission of proteinuria [ Time Frame: baseline and 12 months ]Change in proteinuria at baseline versus after 12 months of treatment.
- 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
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
|Contact: Paolo Cravedi, MD, PhDfirstname.lastname@example.org|
|Contact: Ibeawuchi Okoroafor, MDemail@example.com|
|Principal Investigator:||Paolo Cravedi, MD, PhD||Icahn School of Medicine at Mount Sinai|