NCT02571842

Rituximab in Recurrent IgA Nephropathy

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Recurrent IgA Nephropathy

Interventions

Type	Name	Description
DRUG	Intravenous Rituximab	\- 375 mg/m2 rituximab be prescribed 4 consecutive monthly
DRUG	ACEI/ARB and corticosteroids	* ACEI or ARB will be prescribed as high as tolerable dose. * Prednisolone will be prescribed starting as 0.5 mg/kg/day then taper off to 5 mg/day within 6-8 weeks

Timeline

• Start date: 2012-01-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-10-08
• Last updated: 2015-10-08

Locations

1 site across 1 country: Thailand