Fibrillary Glomerulonephritis
Conditions
Keywords
fibrillary glomerulonephritis, anti-CD20
Brief summary
This study aims to evaluate the clinical and histological effects of two rituximab-based regimens in fibrillary glomerulonephritis.
Interventions
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).
Sponsors
University of Turin, Italy
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
-Fibrillary glomerulonephritis (biospy proven defined by optical microscopy, immunofluorescence and electron microscopy studies with demonstration of the DNAJB9 protein)
Exclusion criteria
* previous treatment with anti-CD20; pregnant; unable to consent. other concomitant GN.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| renal responce | 0, 3 and 6 months | 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 |
Countries
Italy
Outcome results
None listed