Trial Search Results

Rituximab in Progressive Immunoglobulin A (IgA) Nephropathy

This study was about IgA nephropathy, a form of kidney disease characterized by the presence of blood and protein in the urine. This study was done to determine if the medication rituximab could reduce protein in the patient's urine.

Hypothesis: In patients with progressive IgA nephropathy an intravenous infusion of 1000 mg of rituximab on Day 1 and Day 15 and Days 168 and 182 is superior to conventional therapy in reducing 24 hour proteinuria, and slowing progression of chronic kidney disease.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Mayo Clinic

Collaborator: Biogen

Stanford Investigator(s):

Intervention(s):

  • Drug: Intravenous Rituximab
  • Drug: ACE/ARB
  • Dietary Supplement: Omega-3 Fatty Acid Fish Oil Supplement

Phase:

Phase 4

Eligibility


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 <90 mls/min and >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 <130/80 mmHg. The presence of hypertension is not required for study
   entry, but any patient requiring long term hypertensive medications must have blood
   pressure controlled <130-80 mmHg, to be considered eligible for the study

   - Female patients with IgA will be considered eligible for study entry if they have a
   negative urine or serum pregnancy test at the time of screening are agreeable to 2
   years of contraception

   - Biopsy proven IgA nephropathy and clinical features consistent with Henoch Schonlein
   Purpura will be considered eligible for the study

   - Able to swallow the oral medications

Exclusion Criteria

   - Clinical and histologic evidence of IgA predominant Lupus nephritis

   - Clinical and histologic evidence of idiopathic IgA forms of membranoproliferative
   glomerulonephritis

   - Clinical evidence of cirrhosis, chronic active liver disease or known infection with
   hepatitis B, C or HIV

   - Estimated GFR <30 ml/min/1.73m² at the time of screening

   - Greater than 50% glomerular senescence or cortical scarring on renal biopsy

   - Active systemic infection or history of serious infection within one month of entry

   - History of Crohn's disease or Celiac Sprue

   - Positive pregnancy test or breast feeding at time of study entry or unwilling to
   comply with contraceptive measures

   - Current or recent (within 30 days) exposure to any investigational drug

   - Serum Cr >3.5 mg/dl or Modification of Diet in Renal Disease (MDRD) calculated GFR <30
   mls/min

   - Patients receiving >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: <8.5 gm/dL

   - Platelets: <100,000/mm

   - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >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

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Richard Lafayette, MD
650-736-1822
Recruiting