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Belimumab With Rituximab for Primary Membranous Nephropathy (REBOOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949855
Recruitment Status : Not yet recruiting
First Posted : May 14, 2019
Last Update Posted : October 3, 2019
Sponsor:
Collaborators:
Immune Tolerance Network (ITN)
GlaxoSmithKline
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:

The primary objective of this study is to evaluate the effectiveness of belimumab and intravenous rituximab co-administration at inducing a complete remission (CR) compared to rituximab alone in participants with PM.

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 it is currently being tested in other autoimmune diseases, including lupus nephritis and Sjögren's syndrome.


Condition or disease Intervention/treatment Phase
Membranous Nephropathy MN Drug: Belimumab Drug: Placebo for Belimumab Drug: Rituximab Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy (ITN080AI)
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Part A: Low Proteinuria Group - Belimumab and Rituximab

Open-label pharmacokinetics (PK) phase.

Ten participants with low proteinuria classification will receive belimumab weekly subcutaneous injections (52 doses administered Week 0 to Week 51) and rituximab infusions at Weeks 4 and 6.

Low proteinuria classification: The excretion of ≥4 to <8 g/day of protein by the kidneys in adults. (Normal in adults: 0.15 g/day).

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: 200 mg. administered subcutaneously. A higher weekly dose, 400 mg weekly, per protocol and based on PK analysis, may be indicated for participants with high proteinuria.

Other Name: Benlysta®

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.

Other Name: Rituxan®

Experimental: Part A :High Proteinuria Group - Belimumab and Rituximab

Open-label pharmacokinetics (PK) phase.

Ten participants with high proteinuria classification will receive belimumab weekly subcutaneous injections (52 doses administered Week 0 to Week 51) and rituximab infusions at Weeks 4 and 6.

An adjustment (increase) in prescribed weekly dose may occur, per protocol, if indicated by pharmacokinetics (PK) assay results.

High proteinuria classification: The excretion of ≥8 g/day of protein by the kidneys in adults. (Normal in adults: 0.15 g/day).

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: 200 mg. administered subcutaneously. A higher weekly dose, 400 mg weekly, per protocol and based on PK analysis, may be indicated for participants with high proteinuria.

Other Name: Benlysta®

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.

Other Name: Rituxan®

Experimental: Part B: Low Proteinuria Group - Belimumab and Rituximab
Participants in the low proteinuria classification stratification, based upon Part A, and randomized to this arm, will receive will receive belimumab weekly subcutaneous injections (52 doses administered Week 0 to Week 51) and rituximab infusions at Weeks 4 and 6.
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: 200 mg. administered subcutaneously. A higher weekly dose, 400 mg weekly, per protocol and based on PK analysis, may be indicated for participants with high proteinuria.

Other Name: Benlysta®

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.

Other Name: Rituxan®

Placebo Comparator: Part B: Low Proteinuria Group - Placebo and Rituximab
Participants in the low proteinuria classification stratification, based upon Part A, and randomized to this arm, will receive will receive belimumab placebo weekly subcutaneous injections (52 doses administered Week 0 to Week 51) and rituximab infusions at Weeks 4 and 6.
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: 200 mg. administered subcutaneously. A higher weekly dose, 400 mg weekly, per protocol, may be indicated for participants with high proteinuria.

Other Name: Belimumab placebo

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.

Other Name: Rituxan®

Experimental: Part B :High Proteinuria Group - Belimumab and Rituximab

Participants in the high proteinuria classification stratification, based upon Part A, and randomized to this arm, will receive will receive belimumab weekly subcutaneous injections (52 doses administered Week 0 to Week 51) and rituximab infusions at Weeks 4 and 6.

A higher dose of belimumab, per protocol, will be prescribed in high proteinuria participants, if indicated in Part A.

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: 200 mg. administered subcutaneously. A higher weekly dose, 400 mg weekly, per protocol and based on PK analysis, may be indicated for participants with high proteinuria.

Other Name: Benlysta®

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.

Other Name: Rituxan®

Placebo Comparator: Part A :High Proteinuria Group - Placebo and Rituximab

Participants in the high proteinuria classification stratification, based upon Part A, and randomized to this arm, will receive will receive belimumab placebo weekly subcutaneous injections (52 doses administered Week 0 to Week 51) and rituximab infusions at Weeks 4 and 6.

A higher dose of belimumab placebo, per protocol, will be prescribed in high proteinuria participants, if indicated in Part A.

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: 200 mg. administered subcutaneously. A higher weekly dose, 400 mg weekly, per protocol, may be indicated for participants with high proteinuria.

Other Name: Belimumab placebo

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.

Other Name: Rituxan®




Primary Outcome Measures :
  1. Proportion of Participants in Complete Remission (CR) at Week 104: By Treatment Group [ Time Frame: Week 104 ]
    Defined as proteinuria of ≤ 0.3 g/day with a < 20% decrease in estimated glomerular filtration rate (eGFR) from baseline.


Secondary Outcome Measures :
  1. Proportion of Participants in Complete Remission (CR) at Week 52 and Week 156: By Treatment Group [ Time Frame: Week 52, Week 156 ]
    Defined as proteinuria of ≤ 0.3 g/day with a < 20% decrease in estimated glomerular filtration rate (eGFR) from baseline.

  2. Proportion of Participants in Partial Remission (PR) at Week 52, Week 104 and Week 156: By Treatment Group [ Time Frame: Week 52, Week 104, Week 156 ]
    Defined as a 50% or greater decrease in proteinuria compared to baseline and proteinuria <3.5 g/day with a < 20% decrease in eGFR from baseline.

  3. Proportion of Participants in Complete or Partial Remission at Week 52, Week 104, Week 156: By Treatment Group [ Time Frame: Week 52, Week 104, Week 156 ]
    Those who fulfill criteria for either complete or partial remission, as defined in prior outcome measures.

  4. Time to Relapse for Participants who Achieved Complete Remission (CR) or Partial Remission (PR): By Treatment Group [ Time Frame: Up to 156 Weeks (3 Years) ]

    Relapse is defined as a return of proteinuria ≥ 3.5 g/day after:

    • Achieving a CR, or
    • Achieving and maintaining a PR for at least 12 weeks.

    The first timepoint at which a participant achieves CR or PR will be taken defined as Time 0. Participants will be followed from Time 0 to the first evaluation at which the participant fulfills the definition for relapse.


  5. Level of Proteinuria at Week 52, Week 104 and Week 156: By Treatment Group [ Time Frame: Week 52, Week 104, Week 156 ]
    Method of assessment: 24 hour urine collection for quantitation of protein in the urine.

  6. Proportion of Participants in Complete Remission (CR) and Anti-PLA2R Negative: By Treatment Group [ Time Frame: Week 104 ]
    CR as defined per protocol. Antibodies to the phospholipase A2 receptor 1 (Anti-PLA2R antibodies) are a correlate ot primary MN disease activity.

  7. Proportion of Participants in Partial Remission (PR) and Anti-PLA2R Negative: By Treatment Group [ Time Frame: Week 104 ]
    PR as defined per protocol and in prior outcome measures. Antibodies to the phospholipase A2 receptor 1 (Anti-PLA2R antibodies) are a correlate ot primary MN disease activity.

  8. Proportion of Participants Who are Anti-PLA2R Negative: By Treatment Group [ Time Frame: Week 52, Week104, Week 156 ]
    Antibodies to the phospholipase A2 receptor 1 (Anti-PLA2R antibodies) are a correlate ot primary MN disease activity.

  9. Incidence of Adverse Events (AEs): By Treatment Group [ Time Frame: Week 0 to Week 52 ]

    An AE is any untoward or unfavorable medical occurrence associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.

    For purposes of this study, neither B cell depletion nor proteinuria will be classified as an AE.


  10. Incidence of Grade 3 or Higher Infectious Adverse Events (AEs): By Treatment Group [ Time Frame: Week 0 to Week 52 ]
    Reference: NCI-CTCAE manual titled, National Cancer Institute (NCI)s Common Terminology Criteria for Adverse Events Version 5.0 (published November 27, 2017).

  11. Incidence of Arterial Thromboembolic Events: By Treatment Group [ Time Frame: Week 0 to Week 52 ]
    Peripheral vascular embolism, mesenteric infarct, or myocardial infarction.

  12. Incidence of Venous Thromboembolic Events: By Treatment Group [ Time Frame: Week 0 to Week 52 ]
    Venous thromboembolic event (VTE) is defined as a symptomatic deep vein thrombosis (DVT): the formation of a blood clot in a deep vein, detected by systematic compression ultrasonography, symptomatic DVT, or symptomatic fatal or non-fatal pulmonary embolism (PE). An embolism is a clot in the blood that forms and blocks a blood vessel. A pulmonary embolism is a blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung or one of its branches.

  13. Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, Week 52, Week 104 and Week 156: By Treatment Group [ Time Frame: Week 52, Week 104, Week 156 ]
    A Quality of life (QOL) measure using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100.

  14. Belimumab Exposure After the First 4 Doses of Belimumab [ Time Frame: Week 0, Week 1, Week 2, Week 3 ]
    Pharmacokinetics (PK) Assay -Applicable to Part A of the Study. Belimumab exposure will be assessed using the observed belimumab trough levels (C_min) after 4 weeks (i.e., Week 0, Week 1, Week 2 and Week 3) of subcutaneous dosing. Analysis will be begin after all participants in Part A have reached week 4.


Other Outcome Measures:
  1. EXPLORATORY: Belimumab Levels at Week 4, Week 12, Week 24, Week 36 and Week 52 [ Time Frame: Week 4, Week 12, Week 24, Week 36, Week 52 ]
    Exploratory analyses will be performed combining participant data from Part A with the subgroup of Part B participants treated with belimumab.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible for this study-

  • Primary membranous nephropathy (MN), confirmed by kidney biopsy obtained in the past 36 months;
  • Anti-PLA2R positive;
  • Estimated Glomerular Filtration Rate (eGFR) ≥ 40 ml/min/1.73m^2 while on maximally tolerated renin-angiotensin system (RAS) blockade;
  • Proteinuria:

    • ≥4 and < 8 g/day that has been present for ≥ 3 months while on while on maximally tolerated RAS blockade, or
    • ≥8 g/day while on maximally tolerated RAS blockade.
  • Blood pressure while on maximally tolerated RAS blockade:

    • Systolic blood pressure ≤ 140 mmHg, and
    • Diastolic blood pressure ≤ 90 mmHg

Exclusion Criteria:

Subjects meeting any of the following criteria will not be eligible for this study-

  • Secondary cause of membranous nephropathy (MN) (e.g., systemic lupus erythematosus (SLE), drug, infection, malignancy) suggested by review of the subject's medical history and/or clinical presentation;
  • Rituximab use within the previous 12 months;
  • Rituximab use > 12 months ago:

    • With an undetectable CD19 B cell count, or
    • Did not result in a complete remission (CR) or partial remission (PR) with rituximab treatment alone (e.g., without other immunosuppressive or immunomodulatory therapy).
  • Use of anti-B cell therapy other than rituximab within the previous 12 months (or 5 half-lives, whichever is greater);
  • Cyclophosphamide use within the past 3 months;
  • Use of other immunosuppressive medications, such as cyclosporine or tacrolimus, within the past 30 days;
  • Use of corticosteroids within the past 30 days;
  • Use of any biologic investigational agent, defined as any drug not approved for sale in the country it is used, in the previous 12 months;
  • Use of any non-biologic investigational agent in the past 30 days (or 5 half-lives, which ever is greater);
  • Unstable kidney function defined as > 15% decrease in the Estimated Glomerular Filtration Rate (eGFR) during the previous 3 months;
  • Decrease in proteinuria by 50% or more during the previous 12 months;
  • White blood cell (WBC) count < 3.0 x 10^3/µl;
  • Absolute neutrophil count < 1.5 x 10^3/µl;
  • Moderately severe anemia (hemoglobin <9mg/dL);
  • History of primary immunodeficiency;
  • Serum immunoglobulin A (IgA) < 10 mg/dL;
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = ≥2 times the upper limit of normal (ULN);
  • Positive human immunodeficiency virus (HIV) serology;
  • Positive hepatitis C virus (HCV) serology, unless treated with anti-viral therapy with achievement of a sustained virologic response (undetectable viral load 24 weeks after cessation of therapy);
  • Evidence of current or prior infection with hepatitis B, as indicated by a positive HBsAg, positive HBcAb, or positive HBsAb serology without history of vaccination;
  • Positive QuantiFERON - tuberculosis (TB) Gold test results,

    --Note: Tuberculin Purified Protein Derivative (PPD) test may be substituted for QuantiFERON - TB Gold test.

  • History of malignant neoplasm within the last 5 years,

    --Exception: basal cell or squamous cell carcinoma of the skin treated with local resection only, or carcinoma in situ of the uterine cervix treated locally and with no evidence of metastatic disease for 3 years.

  • Absence of individualized, age-appropriate cancer screening;
  • Women of child-bearing potential who are pregnant, nursing, or unwilling to be sexually inactive or use FDA-approved contraception until study week 104;
  • Acute or chronic infection, including:

    • current use of suppressive therapy for chronic infection,
    • hospitalization for treatment of infection in the past 60 days, or
    • parenteral anti-microbial (including anti-bacterial, anti-viral, or anti-fungal agents) use in the past 60 days for infection.
  • History of anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies, including:

    • rituximab, or
    • belimumab.
  • Evidence of serious suicide risk, including:

    • any history of suicidal behavior in the last 6 months,
    • any suicidal ideation in the last 2 months, or
    • who, in the investigator's judgment, pose a significant suicide risk.
  • Evidence of current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence in the past 12 months;
  • Vaccination with a live vaccine within the past 30 days;
  • Other diseases or conditions which, in the opinion of the investigator, would put the subject at risk or confound the results of the study; or
  • Inability to comply with study and follow-up procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949855


Locations
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United States, Alabama
University of Alabama at Birmingham School of Medicine: Division of Nephrology
Birmingham, Alabama, United States, 35294
United States, California
Stanford University School of Medicine: Division of Nephrology
Stanford, California, United States, 94305
Harbor-UCLA Medical Center:Division of Nephrology and Hypertension
Torrance, California, United States, 90502-2004
United States, Florida
Mayo Clinic Jacksonville: Department of Nephrology and Hypertension
Jacksonville, Florida, United States, 32224
United States, Georgia
Ohio State University Wexner Medical Center: Division of Nephrology
Columbus, Georgia, United States, 43210
University of Minnesota Medical School: Division of Renal Diseases and Hypertension
Duluth, Georgia, United States, 55805
United States, Massachusetts
Boston Medical Center: Renal Medicine
Boston, Massachusetts, United States, 02118
United States, Minnesota
Mayo Clinic Rochester: Department of Nephrology and Hypertension
Rochester, Minnesota, United States, 14642
United States, New York
Columbia University Medical Center: Division of Nephrology
New York, New York, United States, 10032
United States, North Carolina
University of North Carolina School of Medicine: Division of Nephrology and Hypertension, Kidney Center
Chapel Hill, North Carolina, United States, 27516
United States, Pennsylvania
University of Pennsylvania: Department of Medicine: Renal-Electrolyte and Hypertension Division
Philadelphia, Pennsylvania, United States, 19104-4238
United States, Tennessee
Vanderbilt University Medical Center: Division of Nephrology and Hypertension
Franklin, Tennessee, United States, 37064
United States, Washington
University of Washington Providence Medical Research Center: Division of Nephrology
Seattle, Washington, United States, 98101
Canada
University of Toronto, Sunnybrook Health Sciences Centre: Nephrology
Toronto, Canada, M5G 2C4
University of Toronto, Univerrsity Health Network: Nephrology
Toronto, Canada, M5G 2C4
The University of British Columbia: Division of Nephrology
Vancouver, Canada, V6T 1Z4
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN)
GlaxoSmithKline
Investigators
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Study Chair: Patrick Nachman, M.D. University of Minnesota, Department of Medicine, Division of Renal Diseases and Hypertension
Study Chair: Iñaki Sanz, M.D. Emory University, Department of Medicine, Division of Rheumatology

Additional Information:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03949855     History of Changes
Other Study ID Numbers: DAIT ITN080AI
NIAID CRMS ID#:38478 ( Other Identifier: DAIT NIAID )
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Primary Membranous Nephropathy
nephrotic syndrome
Pharmacokinetics (PK) Analysis
Double-Blind (Masked), Placebo-Controlled Clinical Trial
Co-administered belimumab and rituximab
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, Membranous
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Rituximab
Belimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Immunosuppressive Agents