Actively Recruiting
Belimumab With Rituximab for Primary Membranous Nephropathy
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-02-13
58
Participants Needed
20
Research Sites
521 weeks
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
I
Immune Tolerance Network (ITN)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Belimumab With Rituximab for Primary Membranous Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years inclusive
- Diagnosed primary membranous nephropathy confirmed by kidney biopsy within past 5 years or relapsing primary MN confirmed within past 7 years
- Nephrotic syndrome with eGFR over 60 mL/min/1.73m2 and no prior immunosuppressant treatment for nephrotic syndrome, or nephrotic syndrome with contraindication to kidney biopsy without secondary cause
- Positive serum anti-PLA2R antibody test
- eGFR at least 30 mL/min/1.73m2 on maximally tolerated RAS blockade
- Proteinuria at least 4 g/day for 3 months or at least 8 g/day while on maximally tolerated RAS blockade
- Blood pressure controlled with systolic ≤ 140 mmHg and diastolic ≤ 90 mmHg on maximally tolerated RAS blockade
You will not qualify if you...
- Secondary causes of membranous nephropathy such as lupus, drug, infection, or malignancy
- Rituximab use within past 12 months
- Prior rituximab use over 12 months ago without complete or partial remission or with undetectable CD19 B cells
- Use of other anti-B cell therapies within past 12 months
- Cyclophosphamide use within past 3 months
- Use of other immunosuppressive drugs including cyclosporine, tacrolimus, or corticosteroids within past 30 days
- Use of investigational biologic or non-biologic agents within specified recent periods
- Poorly controlled diabetes with HbA1c ≥ 9.0%
- Diabetic glomerulopathy greater than Class I or with poor diabetic control
- Unstable kidney function with >20% eGFR decrease in past 3 months
- Decrease in proteinuria by 50% or more in past 12 months
- Low white blood cell or neutrophil counts
- Moderate to severe anemia (hemoglobin < 9 g/dL)
- History of primary immunodeficiency
- Low serum IgA
- Elevated liver enzymes (ALT or AST ≥ 2x upper limit)
- Positive HIV, untreated hepatitis C, or hepatitis B infection
- Positive tuberculosis test
- Significant lung disease or oxygen requirement
- Recent or active malignancy except certain localized skin or cervical cancers
- Lack of age-appropriate cancer screening
- Women pregnant, nursing, or not using approved contraception until week 104
- Recent or current infections or recent antimicrobial treatment
- History of severe allergic reactions to study medications
- Serious suicide risk or recent suicidal behavior
- Current or recent drug or alcohol abuse
- Recent vaccination with live vaccine
- Other conditions or lab abnormalities that increase risk or may affect study results
- Inability to follow study procedures and visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
University of Alabama at Birmingham School of Medicine: Division of Nephrology
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
University of Arkansas
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
University of California San Francisco
San Francisco, California, United States, 94146
Actively Recruiting
4
Stanford University School of Medicine: Division of Nephrology
Stanford, California, United States, 94305
Actively Recruiting
5
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center:Division of Nephrology and Hypertension
Torrance, California, United States, 90502
Actively Recruiting
6
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
7
Mayo Clinic Jacksonville: Department of Nephrology and Hypertension
Jacksonville, Florida, United States, 32224
Actively Recruiting
8
University of Miami Miller School of Medicine, Div of Nephrology
Miami, Florida, United States, 33136
Actively Recruiting
9
Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
10
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
11
University of Michigan
Ann Arbor, Michigan, United States, 48104
Actively Recruiting
12
University of Minnesota Health Clinical Research Unit
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
13
Washington University in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
14
University of Nebraska
Omaha, Nebraska, United States, 68198
Actively Recruiting
15
Columbia University Medical Center: Division of Nephrology
New York, New York, United States, 10032
Actively Recruiting
16
University of North Carolina School of Medicine: Division of Nephrology and Hypertension, Kidney Center
Chapel Hill, North Carolina, United States, 27599-
Actively Recruiting
17
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
18
Ohio State University Wexner Medical Center: Division of Nephrology
Columbus, Ohio, United States, 43210
Actively Recruiting
19
University of Pennsylvania: Department of Medicine: Renal-Electrolyte and Hypertension Division
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
20
Providence Medical Research Center, Providence Health Care: Nephrology
Spokane, Washington, United States, 99204
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here