Efficacy and Safety of Rituximab to That of Calcineurin Inhibitors in Children With Steroid Dependent Nephrotic Syndrome

PHASE3CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

May 8, 2015

Primary Completion Date

August 31, 2016

Study Completion Date

September 30, 2016

Conditions
Nephrotic Syndrome
Interventions
DRUG

Tacrolimus

Oral Tacrolimus (Tablet form) 0.2mg/kg/day starting dose. Targeting trough level of Tacrolimus (T0) 5-7 ng/ml.

DRUG

Rituximab

Two rituximab infusions will be administered once every week at standard dose (Intravenous infusion of rituximab 375mg/mt2). Circulating B cells will be measured 24 hours after rituximab administration. If \>5 B cells per mm3, it will be measured again after 1 week. If count is still \>5 B cells per mm3, third \& fourth doses of rituximab will be given.

Trial Locations (1)

700014

NRS Medical College & Hospital, Kolkata

All Listed Sponsors
lead

Nilratan Sircar Medical College

OTHER_GOV

NCT02438982 - Efficacy and Safety of Rituximab to That of Calcineurin Inhibitors in Children With Steroid Dependent Nephrotic Syndrome | Biotech Hunter | Biotech Hunter