Rituximab in Recurrent IgA Nephropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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

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Recurrent IgA Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rituximab

Drug: Rituximab

•Rituximab 375 mg/m2 on treatment month 1, 2, 3, 4

Other Name: Mabthera

Group Type EXPERIMENTAL

Intravenous Rituximab

Intervention Type DRUG

\- 375 mg/m2 rituximab be prescribed 4 consecutive monthly

ACEI/ARB plus corticosteroids

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

Group Type ACTIVE_COMPARATOR

ACEI/ARB and corticosteroids

Intervention Type DRUG

* 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

Interventions

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Intravenous Rituximab

\- 375 mg/m2 rituximab be prescribed 4 consecutive monthly

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Mabthera "Enalapril", "Lorsartan", "Prednisolone

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No