Skip to main content
OpenTrials
Completed

NCT Number: NCT06680349

Two Anti-CD20 Regimens for Fibrillary Glomerulonephritis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fibrillary Glomerulonephritis

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

San Giovanni Bosco Hub Hospital

Torino, 10154, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. renal responce

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Acronym: CD20FG

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.