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This study aims to evaluate the clinical and histological effects of two rituximab-based regimens in fibrillary glomerulonephritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-CD20 alone | Active Comparator | Lymphoma Protocol consisting of four weekly doses of 375 mg/m2 of rituximab (RTX) |
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| IBCDT | Experimental | Intensive B-cell depletion therapy (IBCDT) which is based on the combination of RTX (given at the dose of 375 mg/m2 every 4 weeks followed by 2 additional doses after 1 and 2 months), CYC (two pulses of 10 mg/kg, corrected according to renal function, on days 4 and 17) and methylprednisolone (three bolus doses of 15 mg/kg) followed by oral prednisone (starting dose 50 mg tapered until complete discontinuation in 4 months). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-CD20 antibodies | Drug | comparing anti-CD20 (lymphoma protcol, RTX 375 mg/m2 every 4 weeks ) alone Vs. Intensive B-cell depletion therapy (IBCDT) which is based on the combination of RTX (given at the dose of 375 mg/m2 every 4 weeks followed by 2 additional doses after 1 and 2 months), cyclophosphamide (two pulses of 10 mg/kg, corrected according to renal function, on days 4 and 17) and methylprednisolone (three bolus doses of 15 mg/kg) followed by oral prednisone (starting dose 50 mg tapered until complete discontinuation in 4 months). |
| Measure | Description | Time Frame |
|---|---|---|
| renal responce | complete remission (CR), i.e., decrease of proteinuria to <0.5g/day with normal or stable renal function (< 20% increase in serum creatinine); partial remission (PR), i.e., reduction in proteinuria by ≥50% with stable renal function | 0, 3 and 6 months |
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Inclusion Criteria:
-Fibrillary glomerulonephritis (biospy proven defined by optical microscopy, immunofluorescence and electron microscopy studies with demonstration of the DNAJB9 protein)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Giovanni Bosco Hub Hospital | Torino | Torino | 10154 | Italy |
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