Rituximab in Progressive Immunoglobulin A (IgA) Nephropathy
Condition: IgA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      Recent clinical success in the use of Rituximab in the treatment of Lupus nephritis and other
      forms immune complex glomerulonephritis has led to its investigation in the treatment of IgA
      nephropathy. Because IgA class antibodies have comparatively short half-lives and that
      deposition of polymeric forms of IgA contributes to glomerular injury, the researchers
      speculated that the reduction of circulating IgA could reduce proteinuria and injury in
      patients with IgA nephropathy.

      Treatment and Follow-up:

      Subjects were randomly assigned to receive rituximab or to continue standard care. Both arms
      received a Omega-3 Fatty Acid Fish Oil Supplement and angiotensin converting enzyme (ACE)
      inhibitors and/or Angiotensin II receptor blockers (ARBs). ACE inhibitors and/or ARBs were
      used to achieve a blood pressure goal of <130/80 mmHg.

      The study was an open-label trial; those assigned to rituximab received a 1 g infusion of
      rituximab followed by an identical dose 2 weeks later. Premedication with corticosteroids (10
      mg dexamethasone intravenously) was also given 30 min prior to the first infusion of each
      series of rituximab. They received an identical 2 g course of rituximab 6 months later.
      Subjects were assessed at least every 3 months or as needed for clinical events. This
      assessment included physical examination, a questionnaire for adverse events, and measurement
      of routine hematology, serum chemistry, timed urine protein excretion, and for those assigned
      to rituximab, B-cell subsets. Follow-up was considered complete at 12 months.
    

Intervention name(s): Intravenous Rituximab; ACE/ARB; Omega-3 Fatty Acid Fish Oil Supplement
Intervention type(s): Drug; Drug; Dietary Supplement
Intervention description(s): Rituximab Therapy [27 Patients]
Rituximab 1 gm IV on Treatment Day 1
Rituximab 1 gm IV on Treatment Day 15
Rituximab 1 gm IV on Treatment Day 168
Rituximab 1 gm IV on Treatment Day 182; ACE inhibitors and /or ARBs will be used to achieve a blood pressure goal of <130/80 millimeters of mercury (mmHg). Patients not attaining the target blood pressure with an ACE inhibitor or ARB alone should be treated with the combination of ACE inhibitor (ACEi) + ARB; Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day
Other intervention name(s): Rituxan; Angiotensin II blockade
Intervention MeSH terms: Rituximab; Angiotensin II
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Estimated glomerular filtration rate (GFR); Proteinuria; Renal Fibrosis