Two Anti-CD20 Regimens for Fibrillary Glomerulonephritis

NCT ID: NCT06680349

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-01-02

Brief Summary

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

Conditions

Fibrillary Glomerulonephritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anti-CD20 alone

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

Group Type: ACTIVE_COMPARATOR

Anti-CD20 antibodies

Intervention Type: 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).

IBCDT

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).

Group Type: EXPERIMENTAL

Anti-CD20 antibodies

Intervention Type: 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).

Interventions

Anti-CD20 antibodies

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).

Intervention Type: DRUG

Eligibility Criteria

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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

San Giovanni Bosco Hub Hospital

Torino, Torino, Italy

Countries

Italy

Other Identifiers

FIBR01

Identifier Type: -

Identifier Source: org_study_id