Clinical Trial: Rituximab in Recurrent IgA Nephropathy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized, Prospective, Open-Label Study of Rituximab in the Treatment of Recurrent IgA Nephropathy With Active Endocapillary Proliferation Pathology

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Chulalongkorn University

Current Primary Outcome:

  • Remission rate [ Time Frame: 12 months ]
    Percentage of patients in each group achieving complete or partial response determined by proteinuria and 24-hour creatinine clearance
  • Incidence of all adverse events [ Time Frame: 12 months ]
    The incidence of adverse events such as serious infection, allergy, fever, headache, etc.


Original Primary Outcome: Same as current

Current Secondary Outcome: Change in allograft pathology following treatment [ Time Frame: 12 months ]

The difference of active and chronic score report by BANFF score, HAAS, Oxford criteria between pre-treatment and post-treatment


Original Secondary Outcome: Same as current

Information By: Chulalongkorn University

Dates:
Date Received: October 6, 2015
Date Started: January 2012
Date Completion: December 2016
Last Updated: October 7, 2015
Last Verified: October 2015