Is NCT03949855 recruiting in San Francisco, CA?

Yes, NCT03949855 is currently recruiting participants at its San Francisco, CA location. This membranous nephropathy clinical trial is actively enrolling qualified participants.

How do I join the membranous nephropathy clinical trial in San Francisco?

To join this clinical trial in San Francisco, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this San Francisco clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Membranous Nephropathy Clinical Trial in San Francisco, CA

About This Membranous Nephropathy Study in San Francisco

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 recog

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Who Can Participate

Inclusion Criteria

Subjects 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 without evidence of a secondary cause of nephrotic syndrome

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

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 urine collection. Or,

≥ 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

Exclusion Criteria

Subjects 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 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 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 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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in San Francisco?

Yes, this clinical trial (NCT03949855) has an active research site in San Francisco, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Membranous Nephropathy Treatment Options in San Francisco, CA

If you're searching for membranous nephropathy treatment options in San Francisco, CA, this clinical trial (NCT03949855) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our San Francisco research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced membranous nephropathy specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all membranous nephropathy clinical trials near you to find additional studies recruiting in your area.

Membranous Nephropathy Clinical Trial in San Francisco, CA

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