Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy

Study Overview
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Brief Summary
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A single-center random parallel study to compare the efficacy and safety of Mycophenolate mofetil versus intravenous Cyclophosphamide pulses in the treatment of crescentic IgA nephropathy

Detailed Description
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IgA nephropathy is an immune-complex glomerulopathy that can result in capillary necrosis or extracapillary proliferation (crescents). Several studies have documented a higher incidence of hypertension and nephritic-range proteinuria in patients with the crescentic form of IgA nephropathy, suggesting that patients with this variant of the disease may have a worse prognosis. Some studies have shown that treatment with steroids and cyclophosphamide had efficacy on reducing proteinuria and preserving renal function by healing vasculitic lesions, therefore preventing the progression of glomerular sclerosis. Recent studies have also shown that mycophenolate mofetil is effective in the treatment of lupus nephritis with vasculitic lesion and small vasculitis with renal involvement. We will conduct a single-center prospective open-labeled clinical trial of 40 patients with crescentic IgA nephropathy and treat them randomly with pulse intravenous cyclophosphamide or oral mycophenolate mofetil. After 12 months of treatment, we will assess the efficacy, safety, tolerability and relapse of mycophenolate mofetil compared with cyclophosphamide in the treatment of crescentic IgA nephropathy.

Official Title
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Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy

Conditions
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IGA Nephropathy

Intervention / Treatment
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* Drug: Mycophenolate mofetil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with a diagnosis of IgAN without deposition of C4 and C1q, age 10-70y, sex free Gross hematuria or an active urine sediment Segmental necrotizing lesion of the capillary wall Cellular or fibrocellular crescents ≥ 10% Fibrinoid degeneration of small vessels Fibrin positive Three or more items, with provision of criteria informed consent Exclusion Criteria: More than four-week treatment with cytotoxic drug, such as CTX, CsA and MMF, prior to enrollment Immune deficiency Serum creatinine ≥ 5.0mg/dl Previous malignancy Pregnancy Hepatitis Diabetic mellitus or obesity Severe infection or CVS complications Henoch-Schonlein purpura nephritis, systemic vasculitis, SLE

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mycophenolate mofeti<br> | Drug: Mycophenolate mofetil<br>* MMF,1.0g/d<br>* Other names: MMF,cellcept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy and safety of Mycophenolate mofetil versus intravenous Cyclophosphamide pulses in the treatment of crescentic IgA nephropathy |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crescentic IgA nephropathy, Mycophenolate mofetil, Cyclophosphamide, treatment