Condition: Membranous Nephropathy · Nephrotic Syndrome · Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
The primary objective of this study is to evaluate the effectiveness of belimumab and intravenous rituximab co-administration at inducing a complete or partial remission (CR or PR) compared to rituximab alone in participants with primary membranous nephropathy. Background: Primary membranous nephropathy (MN) is among the most common causes of nephrotic syndrome in adults. MN affects individuals of all ages and races. The peak incidence of MN is in the fifth decade of life. Primary MN is recognized to be an autoimmune disease, a disease where the body's own immune system causes damage to kidneys. This damage can cause the loss of too much protein in the urine. Drugs used to treat MN aim to reduce the attack by one's own immune system on the kidneys by blocking inflammation and reducing the immune system's function. These drugs can have serious side effects and often do not cure the disease. There is a need for new treatments for MN that are better at improving the disease while reducing fewer treatment associated side effects. In this study, researchers will evaluate if treatment with a combination of two different drugs, belimumab and rituximab, is effective at blocking the immune attacks on the kidney compared to rituximab alone. Rituximab works by decreasing a type of immune cell, called B cells. B cells are known to have a role in MN. Once these cells are removed, disease may become less active or even inactive. However, after stopping treatment, the body will make ne…
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| University of Alabama at Birmingham School of Medicine: Division of Nephrology | Birmingham, Alabama, United States | Recruiting |
| University of Arkansas | Little Rock, Arkansas, United States | Recruiting |
| University of California San Francisco | San Francisco, California, United States | Recruiting |
| Stanford University School of Medicine: Division of Nephrology | Stanford, California, United States | Recruiting |
| The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center:Division of Nephrology and Hypertension | Torrance, California, United States | Recruiting |
| University of Colorado | Aurora, Colorado, United States | Recruiting |
| Mayo Clinic Jacksonville: Department of Nephrology and Hypertension | Jacksonville, Florida, United States | Recruiting |
| University of Miami Miller School of Medicine, Div of Nephrology | Miami, Florida, United States | Recruiting |
| Johns Hopkins | Baltimore, Maryland, United States | Recruiting |
| National Institutes of Health Clinical Center | Bethesda, Maryland, United States | Recruiting |
| University of Michigan | Ann Arbor, Michigan, United States | Recruiting |
| University of Minnesota Health Clinical Research Unit | Minneapolis, Minnesota, United States | Recruiting |
+ 8 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03949855