Belimumab With Rituximab for Primary Membranous Nephropathy
Public ClinicalTrials.gov record NCT03949855. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy (ITN080AI)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 new B cells which may cause disease to become active again. Belimumab works by decreasing the new B cells produced by the body and, may even change the type of new B cells subsequently produced. Belimumab is approved by the US Food and Drug Administration (FDA) to treat systemic lupus erythematosus (also referred to as lupus or SLE). Rituximab is approved by the FDA to treat some types of cancer, rheumatoid arthritis, and vasculitis. Neither rituximab nor belimumab is approved by the FDA to treat MN. Treatment with a combination of belimumab and rituximab has not been studied in individuals with MN, but has been tested in other autoimmune diseases, including lupus nephritis and Sjögren's syndrome.
Study identification
- NCT ID
- NCT03949855
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 58 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 5, 2020
- Primary completion
- Feb 28, 2029
- Completion
- Feb 28, 2030
- Last update posted
- Jul 20, 2026
2020 – 2030
United States locations
- U.S. sites
- 20
- U.S. states
- 15
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham School of Medicine: Division of Nephrology | Birmingham | Alabama | 35294 | Recruiting |
| University of Arkansas | Little Rock | Arkansas | 72205 | Recruiting |
| University of California San Francisco | San Francisco | California | 94146 | Recruiting |
| Stanford University School of Medicine: Division of Nephrology | Stanford | California | 94305 | Recruiting |
| The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center:Division of Nephrology and Hypertension | Torrance | California | 90502 | Recruiting |
| University of Colorado | Aurora | Colorado | 80045 | Recruiting |
| Mayo Clinic Jacksonville: Department of Nephrology and Hypertension | Jacksonville | Florida | 32224 | Recruiting |
| University of Miami Miller School of Medicine, Div of Nephrology | Miami | Florida | 33136 | Recruiting |
| Johns Hopkins | Baltimore | Maryland | 21287 | Recruiting |
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | Recruiting |
| University of Michigan | Ann Arbor | Michigan | 48104 | Recruiting |
| University of Minnesota Health Clinical Research Unit | Minneapolis | Minnesota | 55455 | Recruiting |
| Washington University in St. Louis | St Louis | Missouri | 63110 | Recruiting |
| University of Nebraska | Omaha | Nebraska | 68198 | Recruiting |
| Columbia University Medical Center: Division of Nephrology | New York | New York | 10032 | Recruiting |
| University of North Carolina School of Medicine: Division of Nephrology and Hypertension, Kidney Center | Chapel Hill | North Carolina | 27599- | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Recruiting |
| Ohio State University Wexner Medical Center: Division of Nephrology | Columbus | Ohio | 43210 | Recruiting |
| University of Pennsylvania: Department of Medicine: Renal-Electrolyte and Hypertension Division | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Providence Medical Research Center, Providence Health Care: Nephrology | Spokane | Washington | 99204 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03949855, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 20, 2026 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03949855 live on ClinicalTrials.gov.