Rituximab in Recurrent IgA Nephropathy

Chulalongkorn University

Status and phase: Unknown; Phase 4

Conditions: Recurrent IgA Nephropathy

Treatments: Drug: ACEI/ARB and corticosteroids; Drug: Intravenous Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT02571842

WWC-006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any kidney transplant recipients between the age of 18 and 70 years of age and able to give informed consent
• GFR by 24h Creatinine Clearance (CrCl) >30 ml/min/1.73m²
• Biopsy proven recurrent IgA nephropathy with endocapillary proliferation pattern

Exclusion criteria

• Clinical and histologic evidence of IgA combination with other forms of glomerulonephritis
• Clinical evidence of cirrhosis, chronic active liver disease or known infection with hepatitis B, C or HIV
• 24h CrCl <30 ml/min/1.73m² at the time of screening
• Active systemic infection or history of serious infection within one month of entry
• Positive pregnancy test or breast feeding at time of study entry
• Patients receiving >6 months therapy with oral prednisone >5mg/day or glucocorticoid equivalent
• Live vaccine within 28 days of study enrollment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Rituximab

Experimental group

Description:

Drug: Rituximab •Rituximab 375 mg/m2 on treatment month 1, 2, 3, 4 Other Name: Mabthera

Treatment:

Drug: Intravenous Rituximab

ACEI/ARB plus corticosteroids

Active Comparator group

Description:

Drug: ACEI/ARB An ACEI and /or ARBs will be used to achieve proteinuria reduction and a blood pressure goal of <130/80 mmHg. Patients not attaining the target blood pressure with an ACEI or ARB alone should be treated with the combination of ACEI + ARB Corticosteroids will be used as prednisolone 0.5 mg/kg/day with gradually taper off in 6-8 weeks to 5mg/day daily Other Name: Enalapril, Lorsartan, Prednisolone

Treatment:

Drug: ACEI/ARB and corticosteroids