Pilot Study of Rituximab to Treat Fibrillary Glomerulonephritis
Condition: Fibrillary Glomerulonephritis
MeSH terms: Glomerulonephritis
Intervention: rituximab
Intervention description: 1000 mg infusion
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: fibrillary glomerulonephritis; rituximab; Rituxan; MabThera; Zytux™

Summary:

      This pilot study is being done to see if the study medication, Rituximab, preserves kidney
      function after 12 months of taking the drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fibrillary Glomerulonephritis with diagnostic biopsy performed within the last 2 years

          -  Proteinuria >1 gram

          -  Age > 18 years but < 80 years

          -  Adequately controlled blood pressure (BP<140/90 mmHg in >75% of the readings) for at
             least 3 months prior to enrollment with the use of (angiotensin converting enzyme
             inhibitors (ACEi) and/or angiotensin-receptor blockers (ARB), if tolerated.

          -  Women must be post- menopausal, surgically sterile or practicing a medically approved
             method of contraception

          -  Able and willing to give written informed consent and comply with the requirements of
             the study protocol

          -  Adequate renal function as indicated by estimated glomerular filtration rate (GFR) >
             25 mL/min using the Chronic Kidney Disease Epidemiology Collaboration (CKD/EPI)
             formula or a quantified creatinine clearance >25 mL/min, and/or serum creatinine <3.0
             mg/dL in the presence of ACEi/ARB therapy

          -  Adequate bone marrow function, as indicated by hemoglobin >7.0 gm/dL, white count >3.0
             x 10(9), platelet count >100 x 10(9)

          -  Negative chest x-ray within one year

          -  Negative serum pregnancy test (for women of child bearing age)

          -  Normal organ function.

          -  Subject agrees to use an acceptable method of birth control during treatment and for
             twelve months after completion of treatment

          -  Subject has provided written informed consent

          -  Subject agrees to discontinue routine use of non-steroidal anti-inflammatory drugs

          -  Absolute Neutrophil Count (ANC): > 1000/ mm3

          -  Adequate liver function, as indicated by aspartate aminotransferase (AST), alanine
             aminotransferase (ALT), alkaline phosphatase and total bilirubin < 2x upper limit or
             normal unless related to primary disease

          -  Negative HBsAg and anti-hepatitis B (HBc) lab values within 1 year of signing consent

        Exclusion Criteria:

          -  Pregnancy (determined by a serum pregnancy test for all women of childbearing
             potential within 7 days of treatment), or lactating.

          -  Inability to comply with study and/or follow-up procedures

          -  History of HIV (a documented positive lab value within one year of enrollment)

          -  Presence of active infection

          -  New York Heart Association Classification III or IV heart disease

          -  Concomitant malignancies or previous malignancies within the last five years, with the
             exception of adequately treated basal or squamous cell carcinoma of the skin or
             carcinoma in situ of the cervix

          -  History of psychiatric disorder

          -  At the Investigator's discretion, receipt of a live vaccine within 4 weeks prior to
             randomization

          -  At the Investigator's discretion, positive Hepatitis C serology

          -  Known history of diabetes mellitus or a Hemoglobin A1c result > 6.0% within 90 days
             prior to enrollment