Rituximab in Progressive Immunoglobulin A (IgA) Nephropathy

Inclusion Criteria

• Any patient between the age of 18 and 70 years of age and able to give informed consent
• GFR by Cockcroft-Gault or MDRD equations 30 mls/min
• Greater than or equal to 1000 mg of proteinuria/24 hours while on stable ACEi, ARB or renin inhibitor therapy for 2 months. Patients receiving combination ACE or ARB or ACEi and a renin inhibitor for 2 months will only require 500mg/24 hours
• Blood pressure 3.5 mg/dl or Modification of Diet in Renal Disease (MDRD) calculated GFR 6 months therapy with oral prednisone or glucocorticoid equivalent
• Live vaccine within 28 days of study enrollment.

General Safety & Laboratory Exclusion Criteria

• Patients with anaphylaxis and/or known allergic reactions to Rituximab
• Hemoglobin: 2.5 x Upper Limit of Normal unless related to primary disease.
• Previous Treatment with Rituximab(MabThera®/Rituxan®)
• Previous treatment with Natalizumab(Tysabri®)
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
• History of recurrent significant infection or recurrent bacterial infections
• Known active bacterial, viral fungal mycobacterial or atypical mycobacterial infections, but excluding fungal infections of nail beds
• Any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
• Ongoing use of high dose steroids(>10 mg/day)or unstable steroid dose in the past 4 weeks
• Lack of peripheral venous access
• History of drug, alcohol, or chemical abuse within 6 months prior to screening
• Pregnancy (a negative serum or urine pregnancy test will be performed for all women of childbearing potential no later than 7 days prior to treatment) or lactation
• Concomitant or previous malignancies, 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 that would interfere with normal participation in this protocol
• Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
• Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication
• Inability to comply with study and follow-up procedures