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Rituximab in Recurrent IgA Nephropathy

NCT02571842 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-10-08

No results posted yet for this study

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.

Conditions

  • Recurrent IgA Nephropathy

Interventions

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

Sponsors & Collaborators

  • Chulalongkorn University

    lead OTHER

Principal Investigators

  • Wiwat Chancharoenthana, M.D., Ph.D. · Chulalongkorn University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02571842 on ClinicalTrials.gov