Two Anti-CD20 Regimens for Fibrillary Glomerulonephritis

NCT06680349 | Completed Phase 4

• 1 other identifier: FIBR01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fibrillary Glomerulonephritis

Keywords

fibrillary glomerulonephritis; anti-CD20

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Anti-CD20 alone

ACTIVE COMPARATOR

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

Drug: Anti-CD20 antibodies

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).

Drug: Anti-CD20 antibodies

Interventions

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).

Anti-CD20 alone; IBCDT

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Fibrillary glomerulonephritis (biospy proven defined by optical microscopy, immunofluorescence and electron microscopy studies with demonstration of the DNAJB9 protein)

You may not qualify if:

• previous treatment with anti-CD20; pregnant; unable to consent. other concomitant GN.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

San Giovanni Bosco Hub Hospital

Torino, Torino, 10154, Italy

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 8, 2024
• Study Start: December 1, 2022
• Primary Completion: January 2, 2024
• Study Completion: January 2, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)