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New treatment option for Membranous Nephropathy
Official title Belimumab With Rituximab for Primary Membranous Nephropathy
ClinicalTrials.gov ID: NCT03949855
What this study is testing
What is Belimumab?
Belimumab is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for membranous nephropathy.
Also referred to as Benlysta®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- people must meet all of the following criteria to be eligible for this study-
- Age 18 to 75 years inclusive
- Diagnosis of one of the following:
- Primary MN confirmed by a kidney biopsy within the past 5 years
- 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
You likely can't join if
- people meeting any of the following criteria will not be eligible for this study-
- Secondary cause of MN (e.g., SLE, drug, infection, malignancy) suggested by review of the patient'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 CR (Section 3.3.1) or PR (Section 3.3.2) with rituximab treatment alone (e.g., without other immunosuppressive or...
See the full eligibility criteria
Who can join
- people must meet all of the following criteria to be eligible for this study-
- Age 18 to 75 years inclusive
- Diagnosis of one of the following:
- Primary MN confirmed by a kidney biopsy within the past 5 years
- 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
- 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...
- 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...
- Serum anti-PLA2R positive
- eGFR ≥ 30 mL/min/1.73m2 while on maximally tolerated RAS blockade
- Proteinuria:
- ≥ 4 and \< 8 g/day that has persisted for at least the previous 3 months while on maximally tolerated RAS blockade. Documentation of persistent proteinuria may be from a 24-hour collection or calculated from a spot...
- ≥ 8 g/day while on maximally tolerated RAS blockade
- Blood pressure while on maximally tolerated RAS blockade:
- Systolic blood pressure ≤ 140 mmHg
- Diastolic blood pressure ≤ 90 mmHg
What rules you out
- people meeting any of the following criteria will not be eligible for this study-
- Secondary cause of MN (e.g., SLE, drug, infection, malignancy) suggested by review of the patient'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 CR (Section 3.3.1) or PR (Section 3.3.2) 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 systemic 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, whichever is greater)
- Poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) ≥ 9.0%
- Patients with diabetic glomerulopathy on renal biopsy that is:
- Greater than Class I diabetic glomerulopathy, or
- Class I diabetic glomerulopathy with a history of poor diabetic control (e.g., HbA1c ≥ 9.0%) since time of biopsy
- Unstable kidney function defined as \> 20% decrease in eGFR during the previous 3 months due to primary MN, as determined by the site investigator in consultation with the protocol chair
- Decrease in proteinuria by 50% or more during the previous 12 months
- WBC count \< 3.0 x 103/μl
- Absolute neutrophil count \< 1.5 x 103/μl
- Moderately severe anemia (hemoglobin \< 9 g/dL)
- History of primary immunodeficiency
- Serum IgA \< 10 mg/dL
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2x the upper limit of normal (ULN)
- Positive HIV serology
- Positive 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 positive HBsAg or positive HBcAb
- Positive QuantiFERON - TB Gold test results. PPD tuberculin test may be substituted for QuantiFERON - TB Gold test
- History of lung disease with FVC \< 70% predicted, DLCO \< 70% predicted, or requiring supplemental oxygen
- History of malignant neoplasm within the last 5 years except for 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...
- 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 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...
- History of an anaphylactic reaction or known sensitivity or intolerance 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 and/or any suicidal ideation in the last 2 months, or who in the investigator's judgment, poses 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 or other clinically significant abnormal laboratory value which in the opinion of the investigator would put the patient at risk or confound the results of the study
- Inability to comply with study and follow-up procedures
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Little Rock, Arkansas, United States
- San Francisco, California, United States
- Stanford, California, United States
- Torrance, California, United States
- Aurora, Colorado, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Baltimore, Maryland, United States
- Bethesda, Maryland, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Spokane, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Little Rock, Arkansas, United States; San Francisco, California, United States; Stanford, California, United States; Torrance, California, United States; Aurora, Colorado, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.