drugset / Trial / NCT05704400

Efficacy of Anti-CD20 Ab Associated With Anti-CD38 in the Childhood Multidrug Dependent and Resistant Nephrotic Syndrome

NCT05704400 ↗

Phase 2 Unknown 20 enrolled Gaslini Institute
NaSingle-groupOpen-labelTreatment

Summary

Nephrotic syndrome is considered a disease caused by an interplay of immunological stimuli with adaptive immunity(CD80/CD40) as trigger and Treg in the mid between co-stimulatory molecules and effectors. The positive effect of drugs blocking CD20 maturation in SDNS suggests a main role of these cells in regulating the system. Multidrug dependent, multidrug resistant nephrotic syndrome as well as post transplant FSGS recurrence patients can be considered difficult to treat patients and the association of two drugs, one targeting CD20 and a targeting plasmacells can be use in order to block the stimulatory cascade at more sites.

Timeline

Start
2023-03-01
Primary completion
2024-03-01
Completion
2025-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Daratumumab Monoclonal antibody 16 mg/kg —
Subject Rituximab Monoclonal antibody — Intravenous

Indications