NCT03949855 · National Institute of Allergy and Infectious Diseases (NIAID)
Belimumab With Rituximab for Primary Membranous Nephropathy
(REBOOT)
What this study is about
The primary objective of this study is to evaluate the effectiveness of belimumab and given through a vein (IV) 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.
View original scientific description
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.
Interventions
DRUG
Belimumab
Belimumab is a recombinant, human, IgG1λ monoclonal antibody. Belimumab will be provided as a 200 mg sterile, liquid product in a prefilled syringe. Each syringe contains 1.0 mL of 200 mg/mL belimumab. Each syringe will be a single use. Standard Weekly dose: Part A: 200 mg. administered subcutaneously. Part B: 400 mg (two 200 mg injections) from weeks 0-3, and then 200 mg from weeks 4-51, administered subcutaneously.
DRUG
Placebo for Belimumab
The placebo control will be provided as a sterile liquid product in a prefilled syringe. Each syringe will be of a single use. Standard weekly dose: Part A: 200 mg. administered subcutaneously. Part B: 400 mg (two 200 mg injections) from weeks 0-3, and then 200 mg from weeks 4-51, administered subcutaneously.
DRUG
Rituximab
Rituximab is a monoclonal antibody with specificity for CD20, a transmembrane protein expressed on B cells from the pre-B to memory cell development stages. Rituximab is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-use vials for infusion. It is a clear, colorless liquid. Dose: 1000 mg intravenously (IV), Week 4 and -6.
Primary outcome measures
Proportion of Participants in Complete or Partial Remission (CR or PR) at Week 104.
Time frame: Week 104
. CR is defined as proteinuria of ≤ 0.3 g/day with a serum albumin ≥ 3.5 g/dL. PR is defined as a 50% or greater decrease in proteinuria compared to baseline and proteinuria \< 3.5 g/day glomerular filtration rate (eGFR) from baseline.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects must meet all of the following criteria to be eligible for this study- 1. Age 18 to 75 years inclusive 2. Diagnosis of one of the following: 1. Primary MN confirmed by a kidney biopsy within the past 5 years 2. Primary MN that is relapsing following a CR (Section 3.3.1) or PR (Section 3.3.2), confirmed by a kidney biopsy within the past 7 years 3. Nephrotic syndrome with eGFR \> 60 mL/min/1.73m2 and no history of immunosuppressant treatment (e.g. glucocorticoids, cyclophosphamide, cyclosporine A, tacrolimus, B-cell depleting agent) for nephrotic syndrome, and without evidence of a secondary cause of nephrotic syndrome 4. Nephrotic syndrome and a contraindication to kidney biopsy (e.g., anticoagulation, solitary kidney, body habitus that increases the risk of biopsy, or other contraindication in the opinion of the investigator), and without evidence of a secondary cause of nephrotic syndrome 3. Serum anti-PLA2R positive 4. eGFR ≥ 30 mL/min/1.7
Where
- Birmingham, Alabama
- Little Rock, Arkansas
- San Francisco, California
- Stanford, California
- Torrance, California
- Aurora, Colorado
- Jacksonville, Florida
- Miami, Florida
- Baltimore, Maryland
- Bethesda, Maryland
- Ann Arbor, Michigan
- Minneapolis, Minnesota
And 8 more locations — see the full list below.
Collaborators
Immune Tolerance Network (ITN), GlaxoSmithKline, PPD Development, LP, Rho Federal Systems Division, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 24, 2026 · Source of record for eligibility and locations