Recurrent IgA Nephropathy Clinical Trial
Official title:
A Randomized, Prospective, Open-Label Study of Rituximab in the Treatment of Recurrent IgA Nephropathy With Active Endocapillary Proliferation Pathology
Currently, the treatment options of recurrent IgA nephropathy (IgAN) are conflicting and largely based on expert opinions. Consequently, the recent KDIGO clinical practice guideline for the care of kidney transplant recipients has concluded that there are no definite strategies for prevention and treatment. However, recurrent IgAN in the transplanted kidney is common and may contribute to graft loss, in particular, if cresentic formation, extra- or endocapillary proliferation were presented in kidney pathology. Herein, the investigators assume that rituximab, anti-CD20 Ab agent, can reduce circulating IgA with subsequently decrease rate of polymeric forms of IgA deposition in glomerular capillaries. Therefore, the investigators speculate that rituximab may have potential effect to reduce circulating polymeric forms of IgA and slow progression of recurrent IgAN.
Hypothesis: In kidney transplant recipients with active endocapillary proliferation pathology of recurrent IgAN, an intravenous infusion of 375mg/m2 of rituximab on 4 consecutive monthly dose is superior to conventional therapy in reducing 24-hour proteinuria, and slowing progression of recurrent IgAN. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment