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

PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

March 1, 2023

Primary Completion Date

March 1, 2024

Study Completion Date

March 1, 2025

Conditions
Nephrotic Syndrome
Interventions
DRUG

Rituximab Biosimilar ABP 798

Rituximab IV: the dose is standard for pediatric nephrotic syndrome; for dosage between 100 and 250 mg rituximab will be diluted in 100 ml of normal saline and administered at 2 ml/h for the first 30'; 3 ml/h for the second 30'; 6 ml/h for the third 30'; 15 ml/h until the end. For dosage between 260 and 500 mg rituximab will be diluted in 250 ml of normal saline and administered at 6 ml/h for the first 30'; 9 ml/h for the second 30'; 18 ml/h for the third 30'; 36 ml/h until the end. For dosage between 510 and 1000 mg rituximab will be diluted in 500 ml of normal saline and administered at 9 ml/h for the first 30'; thereafter, the infusion rate can be doubled every 30 minutes up to a maximum of 72 ml/h.

DRUG

Daratumumab

Daratumumab vials 20 mg 1 ml will be collected to reach the desired dose of 16 mg /Kg, the dose is standard recommend to treat myeloma; diluted in 1000 ml of normal saline and infused at the constant speed of 50 ml/h. This will be reduced in case of cutaneous allergic reactions

Trial Locations (1)

16148

RECRUITING

IRCCS G. Gaslini, Genova

All Listed Sponsors
lead

Istituto Giannina Gaslini

OTHER