Two Anti-CD20 Regimens for Fibrillary Glomerulonephritis (CD20FG)

University of Turin

Status and phase: Completed; Phase 4

Conditions: Fibrillary Glomerulonephritis

Treatments: Drug: Anti-CD20 antibodies

Study type: Interventional

Funder types: Other

Identifiers

NCT06680349

FIBR01

Details and patient eligibility

About

This study aims to evaluate the clinical and histological effects of two rituximab-based regimens in fibrillary glomerulonephritis.

Enrollment: 21 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Anti-CD20 alone

Active Comparator group

Description:

Lymphoma Protocol consisting of four weekly doses of 375 mg/m2 of rituximab (RTX)

Treatment:

Drug: Anti-CD20 antibodies

IBCDT

Experimental group

Description:

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).

Treatment:

Drug: Anti-CD20 antibodies