Advances in ANCA-associated vasculitis and lupus nephritis.
Isabelle Ayoub, Patrick H Nachman
https://pubmed.ncbi.nlm.nih.gov/33311560Actively Recruiting
Phase 2
Age: 18Years - 75Years
All Genders
ID03949855
Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy (ITN080AI)
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-19
58
Participants Needed
20
Research Sites
52 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
Researchers are evaluating whether combining belimumab with intravenous rituximab is more effective than rituximab alone in inducing complete or partial remission in adults with primary membranous nephropathy (MN). MN is an autoimmune kidney disease causing protein loss in urine and is a common cause of nephrotic syndrome in adults, typically peaking in the fifth decade of life. Current treatments aim to reduce immune system attacks on the kidneys but can have serious side effects and may not cure the disease, so new therapies are needed. This study has two parts: Part A is an open-label phase assessing belimumab pharmacokinetics in participants with low or high proteinuria, all receiving weekly subcutaneous belimumab and rituximab infusions at weeks 4 and 6 for 52 weeks. Part B is a randomized, double-blind phase where participants receive either belimumab plus rituximab or placebo plus rituximab following a specific dosing schedule for 52 weeks. Participants with inadequate responses at week 30 may receive a second rituximab course. After treatment, participants are followed without study medication until week 156. Participants will undergo regular assessments including blood tests for belimumab levels, proteinuria, anti-PLA2R levels, serum albumin, and kidney function. Researchers will evaluate remission rates at weeks 52, 104, and 156, along with relapse rates and quality of life measures. Safety will be monitored throughout, including tracking adverse events and infections. The total study duration is approximately three years, including treatment and follow-up periods.
CONDITIONS
Brief Title
Belimumab With Rituximab for Primary Membranous Nephropathy
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years inclusive
- Diagnosis of primary membranous nephropathy confirmed by kidney biopsy within the past 5 years or relapsing primary MN confirmed by biopsy within the past 7 years
- Nephrotic syndrome with eGFR > 60 mL/min/1.73m2 and no history of immunosuppressant treatment, or nephrotic syndrome with contraindication to kidney biopsy and no secondary cause
- Serum anti-PLA2R positive
- eGFR ≥ 30 mL/min/1.73m2 while on maximally tolerated RAS blockade
- Proteinuria ≥ 4 and < 8 g/day for at least 3 months, or ≥ 8 g/day while on maximally tolerated RAS blockade
- Blood pressure ≤ 140/90 mmHg while on maximally tolerated RAS blockade
You will not qualify if you...
- Secondary cause of membranous nephropathy (e.g., lupus, drug, infection, malignancy)
- Rituximab use within the previous 12 months
- Prior rituximab use > 12 months ago with undetectable CD19 B cells or no remission
- Use of other anti-B cell therapy within previous 12 months
- Cyclophosphamide use within past 3 months
- Use of cyclosporine, tacrolimus, or systemic corticosteroids within past 30 days
- Use of investigational agents within specified timeframes
- Poorly controlled diabetes (HbA1c ≥ 9.0%) or diabetic glomerulopathy beyond Class I with poor control
- Unstable kidney function (> 20% eGFR decrease in past 3 months)
- Significant blood count abnormalities (WBC < 3.0, neutrophils < 1.5, hemoglobin < 9 g/dL)
- History of primary immunodeficiency
- Low serum IgA (< 10 mg/dL)
- Elevated liver enzymes (ALT or AST ≥ 2x ULN)
- Positive HIV, HCV, or hepatitis B infection
- Positive TB test
- Significant lung disease or oxygen use
- Recent history of cancer except certain skin and cervical cancers
- Lack of age-appropriate cancer screening
- Women pregnant, nursing, or not using contraception until week 104
- Recent or current serious infection or infection treatment
- Allergy or intolerance to study drugs or contrast agents
- Serious suicide risk or recent suicidal behavior
- Current or recent drug or alcohol abuse
- Recent live vaccination
- Other conditions or lab abnormalities increasing risk or confounding results
- Inability to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 52 weeks
Participants receive weekly subcutaneous injections of belimumab or placebo along with rituximab infusions at weeks 4 and 6. At week 30, participants are assessed for response and may receive a second course of rituximab if criteria indicate inadequate response.
Weekly visits for injections and 2 infusions at weeks 4 and 6, plus a response assessment visit at week 30
Follow-up
Duration - Up to 104 weeks following treatment
Participants are followed without study medication to assess remission status and relapse rates up to week 156.
Visits at weeks 52, 104, and 156 for assessments
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
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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