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Belimumab With Rituximab for Primary Membranous Nephropathy
NCT03949855 · View on ClinicalTrials.gov ↗
Study Summary
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
Conditions Studied
Interventions
- DRUG Rituximab
- DRUG Belimumab
- DRUG Placebo for Belimumab
Study Locations (20)
California
- University of California San Francisco — San Francisco
- Stanford University School of Medicine: Division of Nephrology — Stanford
- The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center:Division of Nephrology and Hypertension — Torrance
Florida
- Mayo Clinic Jacksonville: Department of Nephrology and Hypertension — Jacksonville
- University of Miami Miller School of Medicine, Div of Nephrology — Miami
Maryland
- Johns Hopkins — Baltimore
- National Institutes of Health Clinical Center — Bethesda
Ohio
- Cleveland Clinic — Cleveland
- Ohio State University Wexner Medical Center: Division of Nephrology — Columbus
Alabama
- University of Alabama at Birmingham School of Medicine: Division of Nephrology — Birmingham
Arkansas
- University of Arkansas — Little Rock
Colorado
- University of Colorado — Aurora
Michigan
- University of Michigan — Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2020-03-06 |
| Est. Completion | 2030-03-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03949855
The ClinicalTrials.gov registry entry for NCT03949855 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Nephrotic Syndrome appearing as the primary indexed condition, and to 3 interventions — of which Rituximab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03949855 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Florida, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03949855 about?
NCT03949855 is a clinical study titled "Belimumab With Rituximab for Primary Membranous Nephropathy". 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 nephr...
What is the current status of trial NCT03949855?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2020-03-06. Estimated completion is 2030-03-01.
What conditions does trial NCT03949855 study?
This clinical trial studies the following conditions: Nephrotic Syndrome, Membranous Nephropathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03949855?
The interventions under investigation include: Rituximab (DRUG), Belimumab (DRUG), Placebo for Belimumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03949855?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03949855 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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